LCP · Assay, Glycosylated Hemoglobin
Hematology · 21 CFR 864.7470 · Class 2
Overview
| Product Code | LCP |
|---|---|
| Device Name | Assay, Glycosylated Hemoglobin |
| Regulation | 21 CFR 864.7470 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.
Classification Rationale
Class II (performance standards).
Cleared Devices (249)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Nov 22, 2024 | SESE |
| K231465 | Q-Pad Test System | Qurasense | Dec 6, 2023 | SESE |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | Abbott Diagnostics Technologies AS | Sep 27, 2023 | SESE |
| K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | Mar 26, 2020 | SESE |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | Oct 29, 2019 | SESE |
| K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | Aug 15, 2019 | SESE |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | Apr 12, 2019 | SESE |
| K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | Feb 16, 2019 | SESE |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | Skyla Corporation H.S.P.B | Sep 25, 2018 | SESE |
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | Feb 27, 2018 | SESE |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | Nov 21, 2017 | SESE |
| K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | Oct 12, 2017 | SESE |
| K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | Jul 28, 2017 | SESE |
| K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | Jun 16, 2017 | SESE |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | Feb 17, 2017 | SESE |
| K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set | Diazyme Laboratories | Nov 21, 2016 | SESE |
| K142664 | URight Hemoglobin A1c system, FORA A1c System | Taidoc Technology Corporation | Jan 29, 2016 | SESE |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | Sd Biosensor, Inc. | Sep 30, 2015 | SESE |
| K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | Sep 25, 2015 | SESE |
| K141944 | HOME ACCESS AIC TEST | Home Access Health Corp. | Mar 13, 2015 | SESE |
| K142789 | A1c iGear System | Sakae Corporation | Dec 16, 2014 | SESE |
| K133803 | DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT | Diazyme Laboratories | Aug 6, 2014 | SESE |
| K141750 | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM | Infopia Co, Ltd. | Jul 24, 2014 | SESE |
| K140829 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT | Beckman Coulter, Inc. | Jul 14, 2014 | SESE |
| K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | Bio-Rad Laboratories, Inc. | Jun 25, 2014 | SESE |
| K130014 | A1C GEAR SYSTEM | Sakae Corporation | Apr 4, 2014 | SESE |
| K133344 | MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS | Sebia | Mar 28, 2014 | SESE |
| K131307 | ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Jan 24, 2014 | SESE |
| K130990 | VARIANT(TM) II TURBO HBA1C KIT - 2.0 | Bio-Rad Laboratories, Inc., Clinical Systems Divis | May 9, 2013 | SESE |
| K130860 | VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE | Bio-Rad Laboratories, Inc., Clinical Systems Divis | Apr 25, 2013 | SESE |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | Axis-Shield Diagnostics, Ltd. | Dec 12, 2012 | SESE |
| K122101 | CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C | Sebia | Dec 6, 2012 | SESE |
| K122472 | VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM | Bio-Rad Laboratories, Inc., Clinical Systems Divis | Oct 26, 2012 | SESE |
| K120199 | GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY | Beckman Coulter, Inc. | Oct 12, 2012 | SESE |
| K111128 | LABONACHECK A1C | Ceragem International, Inc. | Sep 13, 2012 | SESE |
| K121492 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT | Beckman Coulter, Inc. | Sep 11, 2012 | SESE |
| K121366 | HEMOCUE HBA1C 501 | Infopia Co, Ltd. | Sep 7, 2012 | SESE |
| K113437 | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Aug 6, 2012 | SESE |
| K120497 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL | Medica Corp. | May 14, 2012 | SESE |
| K110313 | TINA-QUANT HBA1C GEN.2 | Roche Diagnostics | Dec 23, 2011 | SESE |
| K112015 | PREMIER HB9210 HBA1C ANALYZER | Primus Corporation Dba Trinity Biotech | Nov 22, 2011 | SESE |
| K110934 | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY | Siemens Healthcare Diagnostics | Aug 25, 2011 | SESE |
| K093548 | AVIE A1C TEST SYSTEM | Mec Dynamics Corp | Jul 20, 2011 | SESE |
| K100547 | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL | Seppim S.A.S. | May 19, 2011 | SESE |
| K110188 | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT | Diazyme Laboratories | May 17, 2011 | SESE |
| K102510 | DIMENSIONS HB1C KIT, MODEL DF105A | Siemens Healthcare Diagnostics | May 13, 2011 | SESE |
| K110056 | AFINION ANALYZER | Axis-Shield Poc AS | Feb 15, 2011 | SESE |
| K102045 | DIMENSION VISA HBA1C, MODEL K3105A | Siemens Heatlhcare Diagnostics, Inc. | Feb 14, 2011 | SESE |
| K102914 | TQ HBA1C GEN3 | Roche | Jan 20, 2011 | SESE |
| K100304 | ST AIA PACK HBA1C | Tosoh Bioscience, Inc. | Aug 27, 2010 | SESE |
| K082275 | CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 | Infopia Co, Ltd. | Jan 14, 2010 | SESE |
| K091711 | S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 | Alfa Wassermann Diagnostic Technologies, Inc. | Dec 11, 2009 | SESE |
| K090699 | VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 | Bio-Rad Laboratories, Inc. | Jul 27, 2009 | SESE |
| K091400 | MODIFICATION TO AVIE A1C TEST SYSTEM | Mec Dynamics Corp | Jun 11, 2009 | SESE |
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC | Bayer Healthcare, LLC | May 14, 2009 | SESE |
| K081269 | AVIE A1C TEST SYSTEM | Mec Dynamics Corp | Mar 20, 2009 | SESE |
| K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS | Siemens Medical Solutions Diagnostics | Jan 8, 2009 | SESE |
| K073309 | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT | Horiba Abx | Oct 17, 2008 | SESE |
| K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | Tosoh Bioscience, Inc. | Sep 16, 2008 | SESE |
| K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID | Jas Diagnostics, Inc. | May 23, 2008 | SESE |
| K072714 | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | Apr 18, 2008 | SESE |
| K072686 | AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS | Axis-Shield Diagnostics, Ltd. | Mar 17, 2008 | SESE |
| K062658 | PRIMUS A1CARE ASSAY | Primus Corp. | Nov 26, 2007 | SESE |
| K071466 | DCA VANTAGE, MODEL 5075 | Siemens Medical Solutions Diagnostics | Oct 9, 2007 | SESE |
| 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 | Jun 25, 2007 | SESE |
| K070452 | VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU | Bio-Rad Laboratories, Inc. | May 7, 2007 | SESE |
| K063306 | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 | Alfa Wassermann, Inc. | Apr 17, 2007 | SESE |
| K070734 | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON | Diazyme Laboratories | Apr 9, 2007 | SESE |
| K063209 | HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL | Thermo Electron OY | Mar 21, 2007 | SESE |
| K063643 | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM | Bio-Rad Laboratories Inc., Clinical Systems Divisi | Dec 27, 2006 | SESE |
| K063400 | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 | Bio-Rad Laboratories, Inc. | Dec 1, 2006 | SESE |
| K060650 | VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 | Ortho-Clinical Diagnostics, Inc. | Apr 6, 2006 | SESE |
| K053411 | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS | Microgenics Corp. | Feb 3, 2006 | SESE |
| K060001 | D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM | Bio-Rad Laboratories, Inc. | Jan 20, 2006 | SESE |
| K052464 | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST | Roche Diagnostics Corp. | Sep 30, 2005 | SESE |
| K051200 | HEMOGLOBIN A1C REAGENT SET | Teco Diagnostics | Aug 8, 2005 | SESE |
| K050574 | AFINION HBALC | Axis-Shield Poc AS | Jul 22, 2005 | SESE |
| K050178 | HBA1C ENZYMATIC ASSAY | General Atomics | Jun 28, 2005 | SESE |
| K051321 | INVIEW | Metrika, Inc. | Jun 13, 2005 | SESE |
| K042459 | SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT | Beckman Coulter, Inc. | Nov 17, 2004 | SESE |
| K042193 | DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT | Diazyme Laboratories | Oct 29, 2004 | SESE |
| K031296 | LIQUI-HEME GLYCO A1C ASSAY | Biodiagnostic Intl | Oct 15, 2004 | SESE |
| K041764 | THE VITROS 5,1 FS CHEMISTRY SYSTEM | Ortho-Clinical Diagnostics | Sep 9, 2004 | SESE |
| K041635 | G5 I HBA1C TEST, G5 II HBA1C TEST | Provalis Diagnostics , Ltd. | Aug 16, 2004 | SESE |
| K041444 | BIO-RAD D-10 DUAL PROGRAM | Bio-Rad Laboratories, Inc. | Jun 9, 2004 | SESE |
| K040872 | VARIANT II HEMOGLOBIN A1C | Bio-Rad Laboratories, Inc. | Apr 15, 2004 | SESE |
| K033674 | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS | Seradyn, Inc. | Feb 9, 2004 | SESE |
| K033847 | A1CNOW FOR HOME AND PROFESSIONAL USE | Metrika, Inc. | Dec 23, 2003 | SESE |
| K031380 | OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) | Olympus America, Inc. | Nov 14, 2003 | SESE |
| K031042 | ATAC HEMOGLOBIN A1C REAGENT KIT | Clinical Data, Inc. | Nov 3, 2003 | SESE |
| K030553 | ARKIT HBA1C | Arkray, Inc. | Sep 2, 2003 | SESE |
| K031043 | D-10 HEMOGLOBIN A1C | Bio-Rad Laboratories, Inc. | Aug 27, 2003 | SESE |
| K031539 | HEMOGLOBIN A1C REAGENT SET | Pointe Scientific, Inc., | Aug 6, 2003 | SESE |
| K023654 | GLYCA-DIRECT FRUCTOSAMINE | Polymedco, Inc. | May 2, 2003 | SESE |
| K023763 | RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS | Randox Laboratories, Ltd. | Jan 13, 2003 | SESE |
| K022661 | A1CNOW FOR HOME USE | Metrika, Inc. | Dec 13, 2002 | SESE |
| K021897 | RANDOX HAEMOGLOBIN A1C | Randox Laboratories, Ltd. | Nov 26, 2002 | SESE |
| K021484 | HEMOGLOBIN A1C CONTROL | Canterbury Scientific , Ltd. | Jun 14, 2002 | SESE |
| K020532 | POLYMEDCO HBA1C TEST | Polymedco, Inc. | Apr 24, 2002 | SESE |
| K020235 | A1CNOW FOR PROFESSIONAL USE | Metrika, Inc. | Feb 15, 2002 | SESE |
| K020234 | A1CNOW FOR RX HOME USE | Metrika, Inc. | Feb 15, 2002 | SESE |
| K013465 | ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT | Diabetes Technologies, Inc. | Jan 22, 2002 | SESE |
| K011852 | DIMENSION HAIC ASSAY, MODEL DF105 | Dade Behring, Inc. | Nov 15, 2001 | SESE |
| K011933 | GLYCOSAL II HBA 1C TEST | Provalis Diagnostics , Ltd. | Nov 2, 2001 | SESE |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | Sigma Diagnostics, Inc. | Oct 26, 2001 | SESE |
| K012525 | THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 | Thermo Dma, Inc. | Oct 4, 2001 | SESE |
| K011434 | G7 AUTOMATED HPLC ANALYZER | Tosoh Medics, Inc. | Sep 18, 2001 | SESE |
| K010748 | SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT | Beckman Coulter, Inc. | Jul 10, 2001 | SESE |
| K003280 | VARIANT II TOTAL GHB | Bio-Rad | Dec 19, 2000 | SESE |
| K003120 | MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C | Roche Diagnostics Corp. | Dec 18, 2000 | SESE |
| K000885 | DRX HBA1C - FOR PRESCRIPTION HOME USE | Metrika, Inc. | Sep 26, 2000 | SESE |
| K001392 | GLYCOSAL HBA1C TEST | Provalis Diagnostics , Ltd. | Aug 21, 2000 | SESE |
| K000887 | DRX HBA1C | Metrika, Inc. | Jul 26, 2000 | SESE |
| K992085 | ABBOTT IMX GLYCATED HEMOGLOBIN II | Abbott Laboratories | May 25, 2000 | SESE |
| K993131 | NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY | Primus, Inc. | May 22, 2000 | SESE |
| K000239 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | Genzyme Corp. | Mar 21, 2000 | SESE |
| K994045 | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 | Primus Corp. | Dec 21, 1999 | SESE |
| K993590 | FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET | Pointe Scientific, Inc., | Dec 21, 1999 | SESE |
| K990899 | HEMOCHEK-A1C SAMPLE COLLECTION KIT | Osborn Group, Inc. | Dec 21, 1999 | SESE |
| K991246 | FRUCTOSAMINE, MODEL FR 106-01 | A.P. Total Care, Inc. | Dec 16, 1999 | SESE |
| K991850 | SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC | Biosafe Laboratories, Inc. | Nov 26, 1999 | SESE |
| K992921 | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II | Primus Corp. | Nov 12, 1999 | SESE |
| K991483 | ABBOTT ARCHITECT GLYCATED HEMOGLOBIN | Abbott Laboratories | Nov 1, 1999 | SESE |
| K990992 | INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC | Roche Diagnostics Corp. | Sep 30, 1999 | SESE |
| K984529 | HEMOCHEK SAMPLE COLLECTION KIT | Osborn Laboratories, Inc. | Jan 28, 1999 | SESE |
| K984268 | VARIANT II HEMOGLOBIN A1C PROGRAM | Bio-Rad | Dec 17, 1998 | SESE |
| K983172 | ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT | Diabetes Technologies, Inc. (Dti) | Nov 30, 1998 | SESE |
| K983726 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | Genzyme Corp. | Nov 25, 1998 | SESE |
| K983253 | PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT | Medisense, Inc. | Nov 20, 1998 | SESE |
| K980888 | GLYCACOR | Exocell, Inc. | Aug 13, 1998 | SESE |
| K973365 | AIC - CHEK (HBAIC-I) | Express-Med, Inc. | Jun 15, 1998 | SESE |
| K974491 | ACCU-CHEK A1C HEMOGLOBIN TEST | Boehringer Mannheim Corp. | May 13, 1998 | SESE |
| K973696 | SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT | Beckman Instruments, Inc. | Nov 24, 1997 | SESE |
| K972265 | A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER | Tosoh Medics, Inc. | Sep 25, 1997 | SESE |
| K971919 | EZCHEK/HBA BLOOD COLLECTION KIT | Flexsite Diagnostics, Inc. | Sep 5, 1997 | SESE |
| K962597 | LXN FRUCTOSAMINE TEST SYSTEM | Lxn Corp. | Jun 13, 1997 | SESE |
| K963844 | HYDRAGEL 15 HB A1C KIT | Morax | Apr 22, 1997 | SESE |
| K961674 | ROCHE UNIMATE FRUCTOSAMINE REAGENT | Roche Diagnostic Systems, Inc. | Sep 27, 1996 | SESE |
| K955087 | HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS | Bayer Corp. | Jun 13, 1996 | SESE |
| K952337 | ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P | Roche Diagnostic Systems, Inc. | Feb 9, 1996 | SESE |
| K946274 | COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN | Helena Laboratories | Jul 11, 1995 | SESE |
| K936285 | ABBOTT VISION GLYCATED HB, MODIFICATION | Abbott Laboratories | Jun 9, 1995 | SESE |
| K951361 | DCA 2000 SYSTEM FOR HEMOGLOBIN A1C | Heraeus Kulzer, Inc. | May 5, 1995 | SESE |
| K941616 | VARIANT TOTAL GHB PROGRAM | Bio-Rad | Apr 14, 1995 | SESE |
| K934070 | TINA-QUANT HEMOGLOBIN A1C | Boehringer Mannheim Corp. | Oct 11, 1994 | SESE |
| K942009 | PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY | Primus Corp. | Sep 14, 1994 | SESE |
| K940971 | AMES DCA 2000 HEMOGLOBIN ALC CONTROLS | Heraeus Kulzer, Inc. | Jul 19, 1994 | SESE |
| K935613 | RADIAS MONOCLONAL HBA 1C ASSAY | Bio-Rad | Apr 5, 1994 | SESE |
| K936204 | GLYCATED HEMOGLOBIN CALIBRATORS | Primus Corp. | Mar 22, 1994 | SESE |
| K940143 | GLYCATED HEMOGLOBIN CONTROLS | Primus Corp. | Mar 15, 1994 | SESE |
| K931183 | GLYCOHEMOGLOBIN | Teco Diagnostics | Nov 5, 1993 | SESE |
| K933287 | 745 GLYCOMAT | Drew Scientific , Ltd. | Sep 9, 1993 | SESE |
| K930823 | PROTEIN-BOUND GLUCOSE ASSAYN KIT | Diagnostic Specialties | Aug 19, 1993 | SESE |
| K926469 | VARIANT(TM) HEMOGLOBIN A 1C PROGRAM | Bio-Rad | Mar 29, 1993 | SESE |
| K925204 | BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED | Beckman Instruments, Inc. | Jan 12, 1993 | SESE |
| K921831 | IMX(R) GLYCATED HEMOGLOBIN | Abbott Laboratories | Sep 29, 1992 | SESE |
| K920820 | MODIFICATION COLUMNMATE | Helena Laboratories | Aug 17, 1992 | SESE |
| K920397 | REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT | Medical Analysis Systems, Inc. | Aug 4, 1992 | SESE |
| K920449 | POINTE 750 GLYCOMETER | Pointe Scientific, Inc., | Jul 28, 1992 | SESE |
| K920198 | GLYCOMAT HAEMOGLOBIN ANALYSER | Drew Scientific , Ltd. | Jul 21, 1992 | SESE |
| K921676 | COLUMNMATE II | Helena Laboratories | Jul 10, 1992 | SESE |
| K921305 | GLYCO-TEK AFFINITY COLUMN KIT | Helena Laboratories | Jun 9, 1992 | SESE |
| K913614 | FRUCTOSAMINE ABG21 TEST SYSTEM | Boehringer Mannheim Corp. | Dec 2, 1991 | SESE |
| K912748 | BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT | Binax, Inc. | Oct 31, 1991 | SESE |
| K905709 | BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT | Beckman Instruments, Inc. | Sep 23, 1991 | SESE |
| K911625 | AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM | Heraeus Kulzer, Inc. | Sep 5, 1991 | SESE |
| K904027 | ABBOTT VISION(TM) GLYCATED HB | Abbott Laboratories | Feb 7, 1991 | SESE |
| K905513 | GLYC-AFFIN(TM)-GA | Isolab, Inc. | Jan 15, 1991 | SESE |
| K904814 | GLYC-AFFIN GP | Isolab, Inc. | Dec 26, 1990 | SESE |
| K896830 | OPTIMATE HEMOGLOBIN A1C | Heraeus Kulzer, Inc. | Sep 11, 1990 | SESE |
| K902457 | ABNORMAL GLYCOHEMOGLOBIN CONTROL | Analytical Control Systems, Inc. | Jul 24, 1990 | SESE |
| K902455 | ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) | Analytical Control Systems, Inc. | Jul 24, 1990 | SESE |
| K896582 | DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) | Primus, Inc. | Jun 28, 1990 | SESE |
| K901414 | COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 | Helena Laboratories | Jun 15, 1990 | SESE |
| K900718 | ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY | Roche Diagnostic Systems, Inc. | Jun 12, 1990 | SESE |
| K896335 | CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR | Creative Laboratory Products, Inc. | Dec 11, 1989 | SESE |
| K896334 | CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER | Creative Laboratory Products, Inc. | Dec 11, 1989 | SESE |
| K895661 | GLYCOTEST II GLYHB ASSAY KIT | Pierce Chemical Co. | Dec 7, 1989 | SESE |
| K893453 | GLYCABEN | Exocell, Inc. | Oct 23, 1989 | SESE |
| K893224 | REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 | Helena Laboratories | Jun 20, 1989 | SESE |
| K891235 | PRIMUS MODEL CLC 330 | Primus, Inc. | Jun 16, 1989 | SESE |
| K884184 | SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE | Sigma Diagnostics, Inc. | Mar 28, 1989 | SESE |
| K884315 | LABILE LYSING REAGENT | Helena Laboratories | Dec 27, 1988 | SESE |
| K880673 | GHB SAMPLE PAPER | Isolab, Inc. | Nov 22, 1988 | SESE |
| K881863 | REP GLYCO SYSTEM | Helena Laboratories | Sep 30, 1988 | SESE |
| K874749 | BINAX EQUATE GLYCOHEMOGLOBIN | Binax, Inc. | Aug 12, 1988 | SESE |
| K882222 | DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY | Bio-Rad | Aug 1, 1988 | SESE |
| K882051 | BIO-RAD HEMOGLOBIN DETECTOR | Bio-Rad | Aug 1, 1988 | SESE |
| K880698 | TITAN GEL-PC GLYCO-HEME(TM) SYSTEM | Helena Laboratories | May 6, 1988 | SESE |
| K873428 | GLYCO-PROBE GSP | Isolab, Inc. | Apr 5, 1988 | SESE |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | Ulster Scientific, Inc. | Feb 17, 1988 | SESE |
| K854010 | FRUCTOSAMINE TEST (ROCHE) | Roche Diagnostic Systems, Inc. | Dec 22, 1987 | SESE |
| K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST | Sandare Chemical Co., Inc. | Sep 29, 1987 | SESE |
| K871679 | FOCUS-GHB | Awareness Technology, Inc. | Jul 28, 1987 | SESE |
| K871388 | MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER | Bio-Rad | Jul 6, 1987 | SESE |
| K864643 | GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT | Pacific Hemostasis | Apr 28, 1987 | SESE |
| K862371 | HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) | Bio-Rad | Sep 16, 1986 | SESE |
| K861697 | SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) | Awareness Technology, Inc. | Aug 19, 1986 | SESE |
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | Sandare Chemical Co., Inc. | Aug 8, 1986 | SESE |
| K860572 | GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET | Pointe Scientific, Inc., | May 16, 1986 | SESE |
Top Applicants
- Helena Laboratories — 19 clearances
- Bio-Rad — 15 clearances
- Bio-Rad Laboratories, Inc. — 8 clearances
- Metrika, Inc. — 7 clearances
- Isolab, Inc. — 7 clearances
