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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013907 | INVERNESS MEDICAL EARLY PREGNANCY TEST | Cambridge Diagnostics Ireland, Ltd. | 2001-12-18 | Special | PDF ↗ |
| K013372 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST | Unipath , Ltd. | 2001-11-09 | Special | PDF ↗ |
| K011551 | SURE CHECK PREGNANCY TEST | Chembio Diagnostic Systems, Inc. | 2001-08-14 | Special | PDF ↗ |
| K012215 | QUIK-CHECK HOME PREGNANCY TEST | ACON Laboratories, Inc. | 2001-08-07 | Traditional | PDF ↗ |
| K002049 | INVERNESS MEDICAL EARLY PREGNANCY TEST | Selfcare, Inc. | 2000-07-27 | Special | PDF ↗ |
| K993483 | ACON ONE STEP HOME PREGNANCY TEST STRIP | ACON Laboratories, Inc. | 2000-01-20 | Traditional | PDF ↗ |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Armkel, LLC | 1999-12-21 | Traditional | PDF ↗ |
| K993333 | CLEARPLAN EASY II HOME PREGNANCY TEST | Unipath , Ltd. | 1999-12-16 | Traditional | PDF ↗ |
| K993141 | AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 | Phamatech | 1999-11-08 | Special | PDF ↗ |
| K991369 | ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY | Germaine Laboratories, Inc. | 1999-05-10 | Traditional | PDF ↗ |
| K991193 | SAS HCG-CHECK | Sa Scientific, Inc. | 1999-05-04 | Traditional | PDF ↗ |
| K990262 | CLEARPLAN EASY HOME PREGNANCY TEST | Unipath , Ltd. | 1999-04-07 | Traditional | PDF ↗ |
| K990576 | OSOM CARD PREGNANCY TEST, MODEL 103 | Wyntek Diagnostics, Inc. | 1999-03-09 | Traditional | PDF ↗ |
| K990373 | FACT PLUS ONE STEP PREGNANCY TEST | Abbott Laboratories | 1999-02-22 | Special | PDF ↗ |
| K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST | Alfa Scientific Designs, Inc. | 1999-02-16 | Traditional | PDF ↗ |
| K983090 | ACON MIDSTREAM PREGNANCY TEST | ACON Laboratories, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K981892 | QUICK & SURE ONESTEP HOME PREGNANCY TEST | Abacus Diagnostics | 1998-08-18 | Traditional | PDF ↗ |
| K981722 | QUIDEL HOME PREGNANCY TEST | Quidel Corp. | 1998-06-03 | Traditional | PDF ↗ |
| K974059 | ONE STEP MIDSTREAM HCG PREGNANCY TEST | International Newtech Development, Inc. | 1998-04-09 | Traditional | PDF ↗ |
| K980532 | QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 | Phamatech | 1998-03-11 | Traditional | PDF ↗ |
| K974821 | BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST | Quidel Corp. | 1998-01-26 | Traditional | PDF ↗ |
| K974021 | SIGNAL PREGNANCY TEST KIT | Sa Scientific, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K974154 | CHOICE ACCU-TEST PREGNANCY TEST KIT | Sa Scientific, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K973570 | QUICK CARD HCG ONE STEP PREGNANCY TEST | Phamatech | 1997-10-31 | Traditional | PDF ↗ |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Armkel, LLC | 1997-10-27 | Traditional | PDF ↗ |
| K973208 | FIRST SIGN | Texas Immunology, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K972682 | QUICKSTICK ONE STEP HCG PREGNANCY TEST | Phamatech | 1997-08-01 | Traditional | PDF ↗ |
| K971286 | EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST | Excel Scientific, Inc. | 1997-05-08 | Traditional | PDF ↗ |
| K970425 | EZ SURE URINE DIPSTICK PREGNANCY HOME TEST | Excel Scientific, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K970008 | ADVANCED QUALITY PREGNANCY TEST | Bionike, Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K965184 | PERFECTA PREGNANCY TEST | Wyntek Diagnostics, Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K970082 | ABBOTT ADVISOR ONE-STEP PREGNANCY TEST | Abbott Laboratories | 1997-01-24 | Traditional | PDF ↗ |
| K963341 | MIDSTREAM ONESTEP PREGNANCY HOME TEST | Syntron Bioresearch, Inc. | 1996-12-02 | Traditional | PDF ↗ |
| K964108 | FACT PLUS PREGNANCY TEST | Direct Access Diagnostics | 1996-11-18 | Traditional | PDF ↗ |
| K964002 | NATURALE HCG PREGNANCY TES | Mizuho USA, Inc. | 1996-11-07 | Traditional | PDF ↗ |
| K962721 | EVIDENCE PREGNANCY TEST | Saliva Diagnostic Systems | 1996-10-01 | Traditional | PDF ↗ |
| K962888 | AFFIRM ONE-STEP HOME PREGNANCY TEST | Athena Medical Corp. | 1996-09-23 | Traditional | PDF ↗ |
| K962580 | EZ SURE ONESTEP EARLY PREGNANCY TEST | Excel Scientific, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K962521 | FACTPLUS ONE STEP PREGNANCY TEST | Direct Access Diagnostics | 1996-07-29 | Traditional | PDF ↗ |
| K962219 | QUICKSTICK ONE STEP PREGNANCY TEST(9010) | Phamatech | 1996-07-23 | Traditional | PDF ↗ |
| K962183 | BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES | Armkel, LLC | 1996-07-10 | Traditional | PDF ↗ |
| K961965 | SURE CHECK PREGNANCY TEST | Chembio Diagnostic Systems, Inc. | 1996-06-24 | Traditional | PDF ↗ |
| K961712 | TBD AT-HOME PREGNANCY TEST | Armkel, LLC | 1996-05-31 | Traditional | PDF ↗ |
| K960733 | MINISTICK PREGNANCY TEST | Vanguard Biomedical Corp. | 1996-05-01 | Traditional | PDF ↗ |
| K960316 | CLEARBLUE EASY | Unipath , Ltd. | 1996-04-29 | Traditional | PDF ↗ |
| K960174 | UNIMARK MIDSTREAM PREGNANCY TEST STICK | Biotech Atlantic, Inc. | 1996-04-01 | Traditional | PDF ↗ |
| K953606 | BEST PREGNANCY TEST | Ameritek, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K960436 | SELFCARE EARLY PREGNANCY TEST | Selfcare, Inc. | 1996-03-19 | Traditional | PDF ↗ |
| K960117 | PLATFORM ONESTEP PREGNANCY HOME TEST | Syntron Bioresearch, Inc. | 1996-03-19 | Traditional | PDF ↗ |
| K955903 | SELFCARE EARLY PREGNANCY TEST | Cambridge Diagnostics Ireland, Ltd. | 1996-03-06 | Traditional | PDF ↗ |
| K954178 | OSOM PREGNANCY TEST | Wyntek Diagnostics, Inc. | 1995-10-23 | Traditional | PDF ↗ |
| K954364 | CAMEO HOME PREGNANCY TEST | Quidel Corp. | 1995-10-13 | Traditional | PDF ↗ |
| K950354 | HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY | Ml Strategies, Inc. | 1995-07-19 | Traditional | PDF ↗ |
| K945514 | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG | Princeton BioMeditech Corp. | 1995-02-10 | Traditional | PDF ↗ |
| K945846 | ADVANCE(R) PREGNANCY TEST | Advanced Care Products | 1995-01-27 | Traditional | PDF ↗ |
| K945568 | HCG MIDSTREAM PREGNANCY TEST | Mizuho USA, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K941765 | HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE | Tcpi, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K941355 | PREGNANCY CHECK | Sa Scientific, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K941771 | BODYWISE PREGNANCEY TEST | Charlton Assoc. | 1994-07-06 | Traditional | PDF ↗ |
| K940637 | PREDICTOR HOME PREGNANCY TEST | Organon Teknika Corp. | 1994-06-02 | Traditional | PDF ↗ |
| K933794 | ANI BIOCARD(TM) HCG TEST | Canadian Bioclinical, Ltd. | 1994-05-19 | Traditional | PDF ↗ |
| K936013 | EVATEST STRIP | Boehringer Mannheim Italia Spa | 1994-02-25 | Traditional | PDF ↗ |
| K934516 | ADVANCE PREGNANCY TEST MODIFICATION | Ortho Pharmaceutical Corp. | 1994-02-24 | Traditional | PDF ↗ |
| K934830 | HCG PREGNANCY ONE STEP TEST STRIP | Tcpi, Inc. | 1993-12-02 | Traditional | PDF ↗ |
| K931997 | HCG MIDSTREAM PREGNANCY TEST | Mizuho USA, Inc. | 1993-09-10 | Traditional | PDF ↗ |
| K930488 | BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST | Syntron Bioresearch, Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K930640 | PRECISE PREGNANCY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-03-18 | Traditional | PDF ↗ |
| K926308 | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST | Princeton Biomedix | 1993-01-26 | Traditional | PDF ↗ |
| K925189 | PREGNAGEN 1-STEP PREGNANCY TEST | Biogenex Laboratories | 1993-01-06 | Traditional | PDF ↗ |
| K925096 | CONCEIVE ONE-STEP PREGNANCY TEST | Quidel Corp. | 1992-12-28 | Traditional | PDF ↗ |
| K921099 | SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST | Syntron Bioresearch, Inc. | 1992-05-29 | Traditional | PDF ↗ |
| K921012 | PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-08 | Traditional | PDF ↗ |
| K914990 | ADVANCE(R) PREGNANCY TEST | Ortho Pharmaceutical Corp. | 1991-12-23 | Traditional | PDF ↗ |
| K914304 | FIRST RESPONSE(R) ONE-STEP | Armkel, LLC | 1991-10-17 | Traditional | PDF ↗ |
| K914254 | HOMECLINIC ONE STEP PREGNANCY TEST | Vanguard Biomedical Corp. | 1991-10-17 | Traditional | PDF ↗ |
| K912316 | QUIKPAC-II ONE STEP PREGNANCY HOME TEST | Syntron Bioresearch, Inc. | 1991-07-24 | Traditional | PDF ↗ |
| K911566 | CLEARBLUE EASY | Unipath , Ltd. | 1991-05-06 | Traditional | PDF ↗ |
| K905742 | CLEARBLUE EASY | Unipath , Ltd. | 1991-02-13 | Traditional | PDF ↗ |
| K904782 | ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST | Carter Products | 1990-12-06 | Traditional | PDF ↗ |
| K901981 | ABBOTT MODIFIED FACT PLUS PREGNANCY TEST | Abbott Laboratories | 1990-08-02 | Traditional | PDF ↗ |
| K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT | Pacific Biotech, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K895560 | MODIFIED HOMECLINIC PREGNANCY TEST | Vanguard Biomedical Corp. | 1989-11-13 | Traditional | PDF ↗ |
| K884489 | C&T PREGNANCY TEST KIT | Healthcheck Corp. | 1989-03-08 | Traditional | PDF ↗ |
| K883430 | PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST | Disease Detection International, Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K883826 | HOME CLINIC PREGNANCY TEST | Vanguard Biomedical Corp. | 1988-11-29 | Traditional | PDF ↗ |
| K882232 | DISCOVER(R) | Carter Products | 1988-10-25 | Traditional | PDF ↗ |
| K882588 | BLUE DOT(TM) TEST FOR PREGNANCY | V-Tech, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K882416 | CLEARBLUE EASY | Unipath , Ltd. | 1988-07-28 | Traditional | PDF ↗ |
| K880472 | ADVANCE* AND DAISY* PREGNANCY TEST | Advanced Care Products | 1988-05-16 | Traditional | PDF ↗ |
| K874823 | FIRST RESPONSE 5 MINUTE PREGNANCY TEST | Tambrands, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 | Leeco Diagnostics, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K874248 | SYNTRON BIORESEARCH U-TEST PREGNANCY TEST | Syntron Bioresearch, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K871601 | ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST | Advanced Care Products | 1987-08-26 | Traditional | PDF ↗ |
| K871996 | ABBOTT BIOTELL PREGNANCY TEST | Abbott Laboratories | 1987-08-18 | Traditional | PDF ↗ |
| K863341 | CARDS(TM) - EARLY PREGNANCY TEST | Pacific Biotech, Inc. | 1987-01-14 | Traditional | PDF ↗ |
| K864373 | CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION) | Unipath , Ltd. | 1987-01-09 | Traditional | PDF ↗ |
| K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 | Leeco Diagnostics, Inc. | 1987-01-09 | Traditional | PDF ↗ |
| K863841 | TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE | Hybritech, Inc. | 1986-12-22 | Traditional | PDF ↗ |
| K862207 | QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION) | Quidel Corp. | 1986-06-17 | Traditional | PDF ↗ |
| K861946 | PTK PLUS. HOME PREGNANCY TEST | Healthcheck Corp. | 1986-06-16 | Traditional | PDF ↗ |
Product code LCX · Class II · Clinical Chemistry. Data: openFDA.