FDA Product Code
FDA Product Code LCX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1155
510(k) Clearances — 226 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-09-09 | Traditional | PDF ↗ |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-07-15 | Traditional | PDF ↗ |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | 2025-02-13 | Traditional | PDF ↗ |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. | 2025-01-31 | Traditional | PDF ↗ |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech., LLC | 2025-01-15 | Traditional | PDF ↗ |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. | 2024-12-20 | Traditional | PDF ↗ |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. | 2024-10-11 | Traditional | PDF ↗ |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2024-08-13 | Traditional | PDF ↗ |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-06-21 | Traditional | PDF ↗ |
| K232715 | Distinct® Digital Pregnancy Test | ACON Laboratories, Inc. | 2024-05-31 | Traditional | PDF ↗ |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | Hangzhou Aichek Medical Technology Co., Ltd. | 2024-04-12 | Traditional | PDF ↗ |
| K234152 | ACESO Early Pregnancy Test | Aceso Laboratories, Inc. | 2024-04-05 | Traditional | PDF ↗ |
| K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | Assure Tech. (Hangzhou) Co, Ltd. | 2024-02-05 | Traditional | PDF ↗ |
| K240025 | Clearblue® Early Detection Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2024-01-31 | Special | PDF ↗ |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | Nantong Egens Biotechnology Co., Ltd. | 2024-01-26 | Traditional | PDF ↗ |
| K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2023-10-13 | Traditional | PDF ↗ |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-02-28 | Traditional | PDF ↗ |
| K222305 | MissLan Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2022-11-30 | Traditional | PDF ↗ |
| K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022-09-21 | Traditional | PDF ↗ |
| K212418 | hCG One Step Pregnancy Test | Healstone Biotech, Inc. | 2022-06-30 | Traditional | PDF ↗ |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream | Co-Innovation Biotech Co., Ltd. | 2022-04-05 | Special | PDF ↗ |
| K210341 | One Step Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022-03-10 | Traditional | PDF ↗ |
| K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 2022-02-18 | Traditional | PDF ↗ |
| K200913 | Clearblue® Early Digital Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2021-08-13 | Traditional | PDF ↗ |
| K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) | Atlas Link Technology Co., Ltd. | 2021-08-04 | Traditional | PDF ↗ |
| K193318 | Distinct® Early Detection Pregnancy Test | ACON Laboratories, Inc. | 2020-08-20 | Traditional | PDF ↗ |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-08-13 | Traditional | PDF ↗ |
| K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream | Hangzhou Clongene Biotech Co., Ltd. | 2019-12-11 | Traditional | PDF ↗ |
| K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream | Innovita (Tangshan) Biological Technology Co., Ltd. | 2019-11-22 | Traditional | PDF ↗ |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream | Qingdao Hightop Biotech Co., Ltd. | 2019-09-05 | Traditional | PDF ↗ |
| K182328 | VeriClear Digital Early Result Pregnancy Test | True Diagnostics, Inc. | 2019-05-15 | Traditional | PDF ↗ |
| K190705 | WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream | Wholepower Biotech Co., Ltd. | 2019-04-15 | Traditional | PDF ↗ |
| K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | Runbio Biotech Co.,Ltd | 2019-02-22 | Traditional | PDF ↗ |
| K183097 | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 2019-01-10 | Traditional | PDF ↗ |
| K180771 | Acro HCG Pregnancy Rapid Test | Acro Biotech, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K172627 | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette | Runbio Biotech Co.,Ltd | 2018-03-28 | Traditional | PDF ↗ |
| K173229 | Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2018-03-12 | Traditional | PDF ↗ |
| K172512 | ACRO HCG Pregnancy Rapid Test | Acro Biotech, Inc. | 2018-02-02 | Special | PDF ↗ |
| K171136 | LIA Pregnancy Test | Lia Diagnostics | 2017-11-20 | Traditional | PDF ↗ |
| K142754 | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test | Sugentech, Inc. | 2016-04-07 | Traditional | PDF ↗ |
| K150063 | One Step hCG Pregnancy Test | Coretests, Inc. | 2015-10-02 | Traditional | PDF ↗ |
| K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | Guangzhou Wondfo Biotech Co., Ltd. | 2015-08-07 | Traditional | PDF ↗ |
| K132085 | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM | Co-Innovation Biotech Co., Ltd. | 2013-11-12 | Traditional | PDF ↗ |
| K131236 | UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP | Ucp Biosciences, Inc. | 2013-11-07 | Traditional | PDF ↗ |
| K123567 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | Church & Dwight Co., Inc. | 2013-09-10 | Traditional | PDF ↗ |
| K123436 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST | Church & Dwight Co., Inc. | 2013-08-26 | Traditional | PDF ↗ |
| K131931 | CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST | Chemtron Biotech, Inc. | 2013-07-26 | Traditional | PDF ↗ |
| K123703 | HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) | Healgen Scientific,, LLC | 2013-04-10 | Traditional | PDF ↗ |
| K122907 | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER | Polymed Therapeutics, Inc. | 2013-03-14 | Traditional | PDF ↗ |
| K123050 | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) | Nantong Biotechnology Co., Ltd. | 2013-02-05 | Traditional | PDF ↗ |
| K112449 | QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST | Tianjin New Bay Bioresearch Co., Ltd. | 2012-09-24 | Traditional | PDF ↗ |
| K103487 | FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST | Taidoc Technology Corporation | 2011-10-04 | Traditional | PDF ↗ |
| K102760 | ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 | Atlas Medical | 2011-08-03 | Traditional | PDF ↗ |
| K103574 | PREGNANCY ONE STEP RAPID TEST | Lehnus & Associates Consulting | 2011-07-28 | Traditional | PDF ↗ |
| K110889 | IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) | Ind Diagnostics, Inc. | 2011-06-20 | Traditional | PDF ↗ |
| K110433 | CLEARBLUE EASY PREGNANCY TEST | SPD Development Company Limited | 2011-05-12 | Special | PDF ↗ |
| K081150 | RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST | Turklab Medical Devices, Inc. | 2009-06-16 | Traditional | PDF ↗ |
| K083716 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) | Church & Dwight Co., Inc. | 2009-06-08 | Traditional | PDF ↗ |
| K071930 | ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C | Blue Cross Bio-Medical Co., Ltd. | 2007-12-18 | Traditional | PDF ↗ |
| K062703 | ONE STEP HCG PREGNANCY TEST | Ai DE Diagnostic Co., Ltd. | 2007-07-23 | Traditional | PDF ↗ |
| K062096 | KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST | Koreamedico Co. , Ltd. | 2007-05-07 | Traditional | PDF ↗ |
| K070054 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | Church & Dwight Co., Inc. | 2007-05-04 | Traditional | PDF ↗ |
| K053236 | DAVID PREGNANCY TEST (MIDSTREAM) | Runbio Biotech Co.,Ltd | 2006-07-18 | Traditional | PDF ↗ |
| K061769 | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST | Unipath , Ltd. | 2006-07-03 | Special | PDF ↗ |
| K060825 | MULTI-USE ELECTRONIC PREGNANCY TEST | Mizuho USA, Inc. | 2006-06-19 | Traditional | PDF ↗ |
| K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | Unipath , Ltd. | 2006-05-25 | Traditional | PDF ↗ |
| K053452 | PURE-AID PREGNANCY TEST | Bio Focus Co., Lt. | 2006-05-25 | Traditional | PDF ↗ |
| K053138 | MYSET PREGNANCY TEST | Ani Biotech OY | 2006-03-01 | Traditional | PDF ↗ |
| K060019 | ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) | Artron Laboratories, Inc. | 2006-02-17 | Traditional | PDF ↗ |
| K051963 | BE-CERTAIN PREGNANCY TEST | Natureplex, LLC | 2005-11-23 | Traditional | PDF ↗ |
| K050305 | ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 | Bioscreen Medical, Inc. | 2005-05-23 | Traditional | PDF ↗ |
| K050546 | ACON +/- MIDSTREAM PREGNANCY TEST | ACON Laboratories, Inc. | 2005-05-20 | Special | PDF ↗ |
| K050930 | E.P.T. CERTAINTY PREGNANCY TEST | Unipath , Ltd. | 2005-05-12 | Special | PDF ↗ |
| K043231 | PROOF POSITIVE ELECTRONIC PREGNANCY TEST | Mizuho USA, Inc. | 2005-04-25 | Traditional | PDF ↗ |
| K043443 | ONE STEP HCG URINE PREGNANCY TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2005-04-08 | Traditional | PDF ↗ |
| K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST | Armkel, LLC | 2004-10-19 | Traditional | PDF ↗ |
| K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT | Unipath , Ltd. | 2004-09-10 | Special | PDF ↗ |
| K042151 | ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST | ACON Laboratories, Inc. | 2004-09-09 | Traditional | PDF ↗ |
| K041748 | AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) | Azog, Inc. | 2004-08-09 | Abbreviated | PDF ↗ |
| K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST | Unipath , Ltd. | 2004-06-08 | Special | PDF ↗ |
| K041273 | ONE-STEP PREGNANCY TEST | W.H.P.M., Inc. | 2004-05-20 | Traditional | PDF ↗ |
| K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST | Unipath , Ltd. | 2004-03-08 | Special | PDF ↗ |
| K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | Unipath , Ltd. | 2004-03-08 | Special | PDF ↗ |
| K033658 | E.P.T. PREGNANCY TEST | Unipath , Ltd. | 2004-01-16 | Special | PDF ↗ |
| K032992 | UNIMARK HOME PREGNANCY TEST DEVICE | Biotech Atlantic, Inc. | 2003-11-21 | Traditional | PDF ↗ |
| K033041 | ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP | ACON Laboratories, Inc. | 2003-11-21 | Traditional | PDF ↗ |
| K031798 | GOOD MORNING TEST | Standard Diagnostics, Inc. | 2003-11-12 | Traditional | PDF ↗ |
| K032939 | EPT CERTAINTY PREGNANCY TEST | Unipath , Ltd. | 2003-10-20 | Special | PDF ↗ |
| K032661 | ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) | ACON Laboratories, Inc. | 2003-10-14 | Traditional | PDF ↗ |
| K032510 | ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST | ACON Laboratories, Inc. | 2003-09-22 | Traditional | PDF ↗ |
| K032159 | CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY | Access Bio Incorporate | 2003-09-05 | Traditional | PDF ↗ |
| K031271 | ONE-STEP PREGNANCY TEST | Amerisource Pharmacal, Inc. | 2003-06-17 | Traditional | PDF ↗ |
| K030659 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | Unipath , Ltd. | 2003-05-02 | Traditional | PDF ↗ |
| K030533 | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST | Cenogenics Corp. | 2003-04-17 | Traditional | PDF ↗ |
| K023037 | MID STREAM PREGNANCY TEST | Advanced Diagnostics, Inc. | 2003-04-09 | Traditional | PDF ↗ |
| K030258 | FIRST RESPONSE PREGNANCY TEST | Armkel, LLC | 2003-02-25 | Traditional | PDF ↗ |
| K023638 | CASSETTE/URINE HCG | Ind Diagnostic, Inc. | 2003-01-03 | Traditional | PDF ↗ |
| K023027 | PREG-Q EARLY PREGNANCY TEST | Yd Diagnostics | 2002-12-16 | Traditional | PDF ↗ |
| K023699 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST | Unipath , Ltd. | 2002-11-27 | Special | PDF ↗ |
| K023126 | AMEDITECH IMMUTEST HCG PREGANCY TEST | Ameditech, Inc. | 2002-11-18 | Traditional | PDF ↗ |
Product code LCX · Class II · Clinical Chemistry. Data: openFDA.