FDA Product Code
FDA Product Code LCP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7470
510(k) Clearances — 249 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-22 | Dual Track | PDF ↗ |
| K231465 | Q-Pad Test System | Qurasense | 2023-12-06 | Traditional | PDF ↗ |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | Abbott Diagnostics Technologies AS | 2023-09-27 | Dual Track | PDF ↗ |
| K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | 2020-03-26 | Traditional | PDF ↗ |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | 2019-10-29 | Traditional | PDF ↗ |
| K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | 2019-08-15 | Traditional | PDF ↗ |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | 2019-04-12 | Traditional | PDF ↗ |
| K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | 2019-02-16 | Dual Track | PDF ↗ |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | Skyla Corporation H.S.P.B | 2018-09-25 | Traditional | PDF ↗ |
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | 2018-02-27 | Traditional | PDF ↗ |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | 2017-11-21 | Special | PDF ↗ |
| K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | 2017-10-12 | Traditional | PDF ↗ |
| K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | 2017-07-28 | Traditional | PDF ↗ |
| K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | 2017-06-16 | Traditional | PDF ↗ |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | 2017-02-17 | Traditional | PDF ↗ |
| K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set | Diazyme Laboratories | 2016-11-21 | Traditional | PDF ↗ |
| K142664 | URight Hemoglobin A1c system, FORA A1c System | Taidoc Technology Corporation | 2016-01-29 | Traditional | PDF ↗ |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | Sd Biosensor, Inc. | 2015-09-30 | Traditional | PDF ↗ |
| K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | 2015-09-25 | Special | PDF ↗ |
| K141944 | HOME ACCESS AIC TEST | Home Access Health Corp. | 2015-03-13 | Traditional | PDF ↗ |
| K142789 | A1c iGear System | Sakae Corporation | 2014-12-16 | Traditional | PDF ↗ |
| K133803 | DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT | Diazyme Laboratories | 2014-08-06 | Traditional | PDF ↗ |
| K141750 | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM | Infopia Co, Ltd. | 2014-07-24 | Special | PDF ↗ |
| K140829 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT | Beckman Coulter, Inc. | 2014-07-14 | Traditional | PDF ↗ |
| K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | Bio-Rad Laboratories, Inc. | 2014-06-25 | Special | PDF ↗ |
| K130014 | A1C GEAR SYSTEM | Sakae Corporation | 2014-04-04 | Traditional | PDF ↗ |
| K133344 | MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS | Sebia | 2014-03-28 | Traditional | PDF ↗ |
| K131307 | ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2014-01-24 | Traditional | PDF ↗ |
| K130990 | VARIANT(TM) II TURBO HBA1C KIT - 2.0 | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-05-09 | Special | PDF ↗ |
| K130860 | VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-04-25 | Special | PDF ↗ |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | Axis-Shield Diagnostics, Ltd. | 2012-12-12 | Traditional | PDF ↗ |
| K122101 | CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C | Sebia | 2012-12-06 | Traditional | PDF ↗ |
| K122472 | VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2012-10-26 | Traditional | PDF ↗ |
| K120199 | GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY | Beckman Coulter, Inc. | 2012-10-12 | Traditional | PDF ↗ |
| K111128 | LABONACHECK A1C | Ceragem International, Inc. | 2012-09-13 | Traditional | PDF ↗ |
| K121492 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT | Beckman Coulter, Inc. | 2012-09-11 | Special | PDF ↗ |
| K121366 | HEMOCUE HBA1C 501 | Infopia Co, Ltd. | 2012-09-07 | Special | PDF ↗ |
| K113437 | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-06 | Traditional | PDF ↗ |
| K120497 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL | Medica Corp. | 2012-05-14 | Traditional | PDF ↗ |
| K110313 | TINA-QUANT HBA1C GEN.2 | Roche Diagnostics | 2011-12-23 | Traditional | PDF ↗ |
| K112015 | PREMIER HB9210 HBA1C ANALYZER | Primus Corporation Dba Trinity Biotech | 2011-11-22 | Traditional | PDF ↗ |
| K110934 | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY | Siemens Healthcare Diagnostics | 2011-08-25 | Traditional | PDF ↗ |
| K093548 | AVIE A1C TEST SYSTEM | Mec Dynamics Corp | 2011-07-20 | Traditional | PDF ↗ |
| K100547 | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL | Seppim S.A.S. | 2011-05-19 | Traditional | PDF ↗ |
| K110188 | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT | Diazyme Laboratories | 2011-05-17 | Special | PDF ↗ |
| K102510 | DIMENSIONS HB1C KIT, MODEL DF105A | Siemens Healthcare Diagnostics | 2011-05-13 | Traditional | PDF ↗ |
| K110056 | AFINION ANALYZER | Axis-Shield Poc AS | 2011-02-15 | Traditional | PDF ↗ |
| K102045 | DIMENSION VISA HBA1C, MODEL K3105A | Siemens Heatlhcare Diagnostics, Inc. | 2011-02-14 | Traditional | PDF ↗ |
| K102914 | TQ HBA1C GEN3 | Roche | 2011-01-20 | Special | PDF ↗ |
| K100304 | ST AIA PACK HBA1C | Tosoh Bioscience, Inc. | 2010-08-27 | Traditional | PDF ↗ |
| K082275 | CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 | Infopia Co, Ltd. | 2010-01-14 | Traditional | PDF ↗ |
| K091711 | S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-12-11 | Traditional | PDF ↗ |
| K090699 | VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 | Bio-Rad Laboratories, Inc. | 2009-07-27 | Traditional | PDF ↗ |
| K091400 | MODIFICATION TO AVIE A1C TEST SYSTEM | Mec Dynamics Corp | 2009-06-11 | Special | PDF ↗ |
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC | Bayer Healthcare, LLC | 2009-05-14 | Special | PDF ↗ |
| K081269 | AVIE A1C TEST SYSTEM | Mec Dynamics Corp | 2009-03-20 | Traditional | PDF ↗ |
| K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS | Siemens Medical Solutions Diagnostics | 2009-01-08 | Traditional | PDF ↗ |
| K073309 | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT | Horiba Abx | 2008-10-17 | Traditional | PDF ↗ |
| K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | Tosoh Bioscience, Inc. | 2008-09-16 | Traditional | PDF ↗ |
| K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID | Jas Diagnostics, Inc. | 2008-05-23 | Traditional | PDF ↗ |
| K072714 | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | 2008-04-18 | Special | PDF ↗ |
| K072686 | AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS | Axis-Shield Diagnostics, Ltd. | 2008-03-17 | Traditional | PDF ↗ |
| K062658 | PRIMUS A1CARE ASSAY | Primus Corp. | 2007-11-26 | Traditional | PDF ↗ |
| K071466 | DCA VANTAGE, MODEL 5075 | Siemens Medical Solutions Diagnostics | 2007-10-09 | Special | PDF ↗ |
| K070819 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2007-06-25 | Traditional | PDF ↗ |
| K070452 | VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU | Bio-Rad Laboratories, Inc. | 2007-05-07 | Traditional | PDF ↗ |
| K063306 | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 | Alfa Wassermann, Inc. | 2007-04-17 | Traditional | PDF ↗ |
| K070734 | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON | Diazyme Laboratories | 2007-04-09 | Special | PDF ↗ |
| K063209 | HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL | Thermo Electron OY | 2007-03-21 | Traditional | PDF ↗ |
| K063643 | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2006-12-27 | Special | PDF ↗ |
| K063400 | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 | Bio-Rad Laboratories, Inc. | 2006-12-01 | Special | PDF ↗ |
| K060650 | VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 | Ortho-Clinical Diagnostics, Inc. | 2006-04-06 | Special | PDF ↗ |
| K053411 | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS | Microgenics Corp. | 2006-02-03 | Traditional | PDF ↗ |
| K060001 | D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM | Bio-Rad Laboratories, Inc. | 2006-01-20 | Special | PDF ↗ |
| K052464 | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST | Roche Diagnostics Corp. | 2005-09-30 | Special | PDF ↗ |
| K051200 | HEMOGLOBIN A1C REAGENT SET | Teco Diagnostics | 2005-08-08 | Traditional | PDF ↗ |
| K050574 | AFINION HBALC | Axis-Shield Poc AS | 2005-07-22 | Traditional | PDF ↗ |
| K050178 | HBA1C ENZYMATIC ASSAY | General Atomics | 2005-06-28 | Traditional | PDF ↗ |
| K051321 | INVIEW | Metrika, Inc. | 2005-06-13 | Special | PDF ↗ |
| K042459 | SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT | Beckman Coulter, Inc. | 2004-11-17 | Traditional | PDF ↗ |
| K042193 | DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT | Diazyme Laboratories | 2004-10-29 | Traditional | PDF ↗ |
| K031296 | LIQUI-HEME GLYCO A1C ASSAY | Biodiagnostic Intl | 2004-10-15 | Traditional | PDF ↗ |
| K041764 | THE VITROS 5,1 FS CHEMISTRY SYSTEM | Ortho-Clinical Diagnostics | 2004-09-09 | Traditional | PDF ↗ |
| K041635 | G5 I HBA1C TEST, G5 II HBA1C TEST | Provalis Diagnostics , Ltd. | 2004-08-16 | Traditional | PDF ↗ |
| K041444 | BIO-RAD D-10 DUAL PROGRAM | Bio-Rad Laboratories, Inc. | 2004-06-09 | Traditional | PDF ↗ |
| K040872 | VARIANT II HEMOGLOBIN A1C | Bio-Rad Laboratories, Inc. | 2004-04-15 | Traditional | PDF ↗ |
| K033674 | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS | Seradyn, Inc. | 2004-02-09 | Traditional | PDF ↗ |
| K033847 | A1CNOW FOR HOME AND PROFESSIONAL USE | Metrika, Inc. | 2003-12-23 | Special | PDF ↗ |
| K031380 | OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) | Olympus America, Inc. | 2003-11-14 | Traditional | PDF ↗ |
| K031042 | ATAC HEMOGLOBIN A1C REAGENT KIT | Clinical Data, Inc. | 2003-11-03 | Traditional | PDF ↗ |
| K030553 | ARKIT HBA1C | Arkray, Inc. | 2003-09-02 | Traditional | PDF ↗ |
| K031043 | D-10 HEMOGLOBIN A1C | Bio-Rad Laboratories, Inc. | 2003-08-27 | Traditional | PDF ↗ |
| K031539 | HEMOGLOBIN A1C REAGENT SET | Pointe Scientific, Inc., | 2003-08-06 | Traditional | PDF ↗ |
| K023654 | GLYCA-DIRECT FRUCTOSAMINE | Polymedco, Inc. | 2003-05-02 | Traditional | PDF ↗ |
| K023763 | RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS | Randox Laboratories, Ltd. | 2003-01-13 | Traditional | PDF ↗ |
| K022661 | A1CNOW FOR HOME USE | Metrika, Inc. | 2002-12-13 | Traditional | PDF ↗ |
| K021897 | RANDOX HAEMOGLOBIN A1C | Randox Laboratories, Ltd. | 2002-11-26 | Traditional | PDF ↗ |
| K021484 | HEMOGLOBIN A1C CONTROL | Canterbury Scientific , Ltd. | 2002-06-14 | Traditional | PDF ↗ |
| K020532 | POLYMEDCO HBA1C TEST | Polymedco, Inc. | 2002-04-24 | Traditional | PDF ↗ |
| K020234 | A1CNOW FOR RX HOME USE | Metrika, Inc. | 2002-02-15 | Special | PDF ↗ |
Product code LCP · Class II · Hematology. Data: openFDA.