Product Code: LCP FDA class 2 21 CFR 864.7470

Assay, Glycosylated Hemoglobin

Hematology

Glycosylated hemoglobin assay is a laboratory test system used in hematology and diabetes management to measure the proportion of hemoglobin that has been glycated, providing an indication of average blood glucose levels over the preceding two to three months. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is LCP, regulated under 21 CFR 864.7470, in the Hematology specialty. No special risk flags apply.

View on FDA

510(k)s

249

FEI Numbers

Registration Numbers

Unique Applicants

118

Years Active

Research product code LCP in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LCP
Device Class: FDA class 2
Regulation Number: 864.7470
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 249 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K221326	Nova Allegro HbA1c Assay, Nova Allegro Analyzer	Nov 22, 2024	Substantially Equivalent	Nova Biomedical Corporation
K231465	Q-Pad Test System	Dec 06, 2023	Substantially Equivalent	Qurasense
K214117	Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer	Sep 27, 2023	Substantially Equivalent	Abbott Diagnostics Technologies AS
K192987	Aina HbA1c Monitoring System 2	Mar 26, 2020	Substantially Equivalent	Jana Care, Inc.
K192369	PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit	Oct 29, 2019	Substantially Equivalent	Ixensor Co, Ltd.
K183230	OneDraw A1C Test System	Aug 15, 2019	Substantially Equivalent	Drawbridge Health, Inc.
K181915	PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit	Apr 12, 2019	Substantially Equivalent	Ixensor Co, Ltd.
K180509	Quo-Test A1c System	Feb 16, 2019	Substantially Equivalent	Ekf-Diagnostic GmbH
K173127	skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)	Sep 25, 2018	Substantially Equivalent	Skyla Corporation H.S.P.B
K170623	ACE Hemoglobin A1c (HbA1c) Reagent	Feb 27, 2018	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, LLC
K171650	Alere Afinion HbA1c and ACR on Afinion 2 analyzer	Nov 21, 2017	Substantially Equivalent	Abbott Rapid Diagnostics
K170147	Lucica Glycated Albumin-L	Oct 12, 2017	Substantially Equivalent	Asahi Kasei Pharma Corporation
K163633	cobas HbA1c Test, cobas b 101 system	Jul 28, 2017	Substantially Equivalent	Roche Diagnostics Operations
K161533	A1C EZ Glycohemoglobin Analysis System	Jun 16, 2017	Substantially Equivalent	Biohermes Co., Ltd.
K162281	CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)	Feb 17, 2017	Substantially Equivalent	Sebia
K160762	Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set	Nov 21, 2016	Substantially Equivalent	Diazyme Laboratories
K142664	URight Hemoglobin A1c system, FORA A1c System	Jan 29, 2016	Substantially Equivalent	Taidoc Technology Corporation
K140827	SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set	Sep 30, 2015	Substantially Equivalent	Sd Biosensor, Inc.
K151809	Alere Afinion HbA1c, Alere Afinion AS100 Analyzer	Sep 25, 2015	Substantially Equivalent	Alere Technologies AS
K141944	HOME ACCESS AIC TEST	Mar 13, 2015	Substantially Equivalent	Home Access Health Corp.
K142789	A1c iGear System	Dec 16, 2014	Substantially Equivalent	Sakae Corporation
K133803	DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT	Aug 06, 2014	Substantially Equivalent	Diazyme Laboratories
K141750	HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM	Jul 24, 2014	Substantially Equivalent	Infopia Co, Ltd.
K140829	UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT	Jul 14, 2014	Substantially Equivalent	Beckman Coulter, Inc.
K140801	VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM	Jun 25, 2014	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K130014	A1C GEAR SYSTEM	Apr 04, 2014	Substantially Equivalent	Sakae Corporation
K133344	MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS	Mar 28, 2014	Substantially Equivalent	Sebia
K131307	ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR	Jan 24, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K130990	VARIANT(TM) II TURBO HBA1C KIT - 2.0	May 09, 2013	Substantially Equivalent	Bio-Rad Laboratories, Inc., Clinical Systems Divis
K130860	VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE	Apr 25, 2013	Substantially Equivalent	Bio-Rad Laboratories, Inc., Clinical Systems Divis
K121842	ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C	Dec 12, 2012	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K122101	CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C	Dec 06, 2012	Substantially Equivalent	Sebia
K122472	VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM	Oct 26, 2012	Substantially Equivalent	Bio-Rad Laboratories, Inc., Clinical Systems Divis
K120199	GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY	Oct 12, 2012	Substantially Equivalent	Beckman Coulter, Inc.
K111128	LABONACHECK A1C	Sep 13, 2012	Substantially Equivalent	Ceragem International, Inc.
K121492	UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT	Sep 11, 2012	Substantially Equivalent	Beckman Coulter, Inc.
K121366	HEMOCUE HBA1C 501	Sep 07, 2012	Substantially Equivalent	Infopia Co, Ltd.
K113437	ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT	Aug 06, 2012	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K120497	EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL	May 14, 2012	Substantially Equivalent	Medica Corp.
K110313	TINA-QUANT HBA1C GEN.2	Dec 23, 2011	Substantially Equivalent	Roche Diagnostics
K112015	PREMIER HB9210 HBA1C ANALYZER	Nov 22, 2011	Substantially Equivalent	Primus Corporation Dba Trinity Biotech
K110934	ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY	Aug 25, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K093548	AVIE A1C TEST SYSTEM	Jul 20, 2011	Substantially Equivalent	Mec Dynamics Corp
K100547	ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL	May 19, 2011	Substantially Equivalent	Seppim S.A.S.
K110188	DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT	May 17, 2011	Substantially Equivalent	Diazyme Laboratories
K102510	DIMENSIONS HB1C KIT, MODEL DF105A	May 13, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K110056	AFINION ANALYZER	Feb 15, 2011	Substantially Equivalent	Axis-Shield Poc AS
K102045	DIMENSION VISA HBA1C, MODEL K3105A	Feb 14, 2011	Substantially Equivalent	Siemens Heatlhcare Diagnostics, Inc.
K102914	TQ HBA1C GEN3	Jan 20, 2011	Substantially Equivalent	Roche
K100304	ST AIA PACK HBA1C	Aug 27, 2010	Substantially Equivalent	Tosoh Bioscience, Inc.
K082275	CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023	Jan 14, 2010	Substantially Equivalent	Infopia Co, Ltd.
K091711	S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023	Dec 11, 2009	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K090699	VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730	Jul 27, 2009	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K091400	MODIFICATION TO AVIE A1C TEST SYSTEM	Jun 11, 2009	Substantially Equivalent	Mec Dynamics Corp
K090413	A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC	May 14, 2009	Substantially Equivalent	Bayer Healthcare, LLC
K081269	AVIE A1C TEST SYSTEM	Mar 20, 2009	Substantially Equivalent	Mec Dynamics Corp
K081895	ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS	Jan 08, 2009	Substantially Equivalent	Siemens Medical Solutions Diagnostics
K073309	ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT	Oct 17, 2008	Substantially Equivalent	Horiba Abx
K071132	G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8	Sep 16, 2008	Substantially Equivalent	Tosoh Bioscience, Inc.
K080618	DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID	May 23, 2008	Substantially Equivalent	Jas Diagnostics, Inc.
K072714	TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM	Apr 18, 2008	Substantially Equivalent	Roche Diagnostics Corp.
K072686	AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS	Mar 17, 2008	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K062658	PRIMUS A1CARE ASSAY	Nov 26, 2007	Substantially Equivalent	Primus Corp.
K071466	DCA VANTAGE, MODEL 5075	Oct 09, 2007	Substantially Equivalent	Siemens Medical Solutions Diagnostics
K070819	VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,	Jun 25, 2007	Substantially Equivalent	Bio-Rad Laboratories Inc., Clinical Systems Divisi
K070452	VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU	May 07, 2007	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K063306	ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72	Apr 17, 2007	Substantially Equivalent	Alfa Wassermann, Inc.
K070734	MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON	Apr 09, 2007	Substantially Equivalent	Diazyme Laboratories
K063209	HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL	Mar 21, 2007	Substantially Equivalent	Thermo Electron OY
K063643	MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM	Dec 27, 2006	Substantially Equivalent	Bio-Rad Laboratories Inc., Clinical Systems Divisi
K063400	VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0	Dec 01, 2006	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K060650	VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702	Apr 06, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K053411	DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS	Feb 03, 2006	Substantially Equivalent	Microgenics Corp.
K060001	D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM	Jan 20, 2006	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K052464	TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST	Sep 30, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K051200	HEMOGLOBIN A1C REAGENT SET	Aug 08, 2005	Substantially Equivalent	Teco Diagnostics
K050574	AFINION HBALC	Jul 22, 2005	Substantially Equivalent	Axis-Shield Poc AS
K050178	HBA1C ENZYMATIC ASSAY	Jun 28, 2005	Substantially Equivalent	General Atomics
K051321	INVIEW	Jun 13, 2005	Substantially Equivalent	Metrika, Inc.
K042459	SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT	Nov 17, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K042193	DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT	Oct 29, 2004	Substantially Equivalent	Diazyme Laboratories
K031296	LIQUI-HEME GLYCO A1C ASSAY	Oct 15, 2004	Substantially Equivalent	Biodiagnostic Intl
K041764	THE VITROS 5,1 FS CHEMISTRY SYSTEM	Sep 09, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics
K041635	G5 I HBA1C TEST, G5 II HBA1C TEST	Aug 16, 2004	Substantially Equivalent	Provalis Diagnostics , Ltd.
K041444	BIO-RAD D-10 DUAL PROGRAM	Jun 09, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K040872	VARIANT II HEMOGLOBIN A1C	Apr 15, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K033674	MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS	Feb 09, 2004	Substantially Equivalent	Seradyn, Inc.
K033847	A1CNOW FOR HOME AND PROFESSIONAL USE	Dec 23, 2003	Substantially Equivalent	Metrika, Inc.
K031380	OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)	Nov 14, 2003	Substantially Equivalent	Olympus America, Inc.
K031042	ATAC HEMOGLOBIN A1C REAGENT KIT	Nov 03, 2003	Substantially Equivalent	Clinical Data, Inc.
K030553	ARKIT HBA1C	Sep 02, 2003	Substantially Equivalent	Arkray, Inc.
K031043	D-10 HEMOGLOBIN A1C	Aug 27, 2003	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K031539	HEMOGLOBIN A1C REAGENT SET	Aug 06, 2003	Substantially Equivalent	Pointe Scientific, Inc.,
K023654	GLYCA-DIRECT FRUCTOSAMINE	May 02, 2003	Substantially Equivalent	Polymedco, Inc.
K023763	RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS	Jan 13, 2003	Substantially Equivalent	Randox Laboratories, Ltd.
K022661	A1CNOW FOR HOME USE	Dec 13, 2002	Substantially Equivalent	Metrika, Inc.
K021897	RANDOX HAEMOGLOBIN A1C	Nov 26, 2002	Substantially Equivalent	Randox Laboratories, Ltd.
K021484	HEMOGLOBIN A1C CONTROL	Jun 14, 2002	Substantially Equivalent	Canterbury Scientific , Ltd.
K020532	POLYMEDCO HBA1C TEST	Apr 24, 2002	Substantially Equivalent	Polymedco, Inc.
K020235	A1CNOW FOR PROFESSIONAL USE	Feb 15, 2002	Substantially Equivalent	Metrika, Inc.
K020234	A1CNOW FOR RX HOME USE	Feb 15, 2002	Substantially Equivalent	Metrika, Inc.
K013465	ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT	Jan 22, 2002	Substantially Equivalent	Diabetes Technologies, Inc.
K011852	DIMENSION HAIC ASSAY, MODEL DF105	Nov 15, 2001	Substantially Equivalent	Dade Behring, Inc.
K011933	GLYCOSAL II HBA 1C TEST	Nov 02, 2001	Substantially Equivalent	Provalis Diagnostics , Ltd.
K012410	INFINITY HBA KIT, MODELS 537-A, 537-B	Oct 26, 2001	Substantially Equivalent	Sigma Diagnostics, Inc.
K012525	THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235	Oct 04, 2001	Substantially Equivalent	Thermo Dma, Inc.
K011434	G7 AUTOMATED HPLC ANALYZER	Sep 18, 2001	Substantially Equivalent	Tosoh Medics, Inc.
K010748	SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT	Jul 10, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K003280	VARIANT II TOTAL GHB	Dec 19, 2000	Substantially Equivalent	Bio-Rad
K003120	MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C	Dec 18, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K000885	DRX HBA1C - FOR PRESCRIPTION HOME USE	Sep 26, 2000	Substantially Equivalent	Metrika, Inc.
K001392	GLYCOSAL HBA1C TEST	Aug 21, 2000	Substantially Equivalent	Provalis Diagnostics , Ltd.
K000887	DRX HBA1C	Jul 26, 2000	Substantially Equivalent	Metrika, Inc.
K992085	ABBOTT IMX GLYCATED HEMOGLOBIN II	May 25, 2000	Substantially Equivalent	Abbott Laboratories
K993131	NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY	May 22, 2000	Substantially Equivalent	Primus, Inc.
K000239	GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL	Mar 21, 2000	Substantially Equivalent	Genzyme Corp.
K994045	PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2	Dec 21, 1999	Substantially Equivalent	Primus Corp.
K993590	FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET	Dec 21, 1999	Substantially Equivalent	Pointe Scientific, Inc.,
K990899	HEMOCHEK-A1C SAMPLE COLLECTION KIT	Dec 21, 1999	Substantially Equivalent	Osborn Group, Inc.
K991246	FRUCTOSAMINE, MODEL FR 106-01	Dec 16, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K991850	SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC	Nov 26, 1999	Substantially Equivalent	Biosafe Laboratories, Inc.
K992921	PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II	Nov 12, 1999	Substantially Equivalent	Primus Corp.
K991483	ABBOTT ARCHITECT GLYCATED HEMOGLOBIN	Nov 01, 1999	Substantially Equivalent	Abbott Laboratories
K990992	INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC	Sep 30, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K984529	HEMOCHEK SAMPLE COLLECTION KIT	Jan 28, 1999	Substantially Equivalent	Osborn Laboratories, Inc.
K984268	VARIANT II HEMOGLOBIN A1C PROGRAM	Dec 17, 1998	Substantially Equivalent	Bio-Rad
K983172	ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT	Nov 30, 1998	Substantially Equivalent	Diabetes Technologies, Inc. (Dti)
K983726	GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL	Nov 25, 1998	Substantially Equivalent	Genzyme Corp.
K983253	PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT	Nov 20, 1998	Substantially Equivalent	Medisense, Inc.
K980888	GLYCACOR	Aug 13, 1998	Substantially Equivalent	Exocell, Inc.
K973365	AIC - CHEK (HBAIC-I)	Jun 15, 1998	Substantially Equivalent	Express-Med, Inc.
K974491	ACCU-CHEK A1C HEMOGLOBIN TEST	May 13, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K973696	SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT	Nov 24, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K972265	A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER	Sep 25, 1997	Substantially Equivalent	Tosoh Medics, Inc.
K971919	EZCHEK/HBA BLOOD COLLECTION KIT	Sep 05, 1997	Substantially Equivalent	Flexsite Diagnostics, Inc.
K962597	LXN FRUCTOSAMINE TEST SYSTEM	Jun 13, 1997	Substantially Equivalent	Lxn Corp.
K963844	HYDRAGEL 15 HB A1C KIT	Apr 22, 1997	Substantially Equivalent	Morax
K961674	ROCHE UNIMATE FRUCTOSAMINE REAGENT	Sep 27, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K955087	HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS	Jun 13, 1996	Substantially Equivalent	Bayer Corp.
K952337	ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P	Feb 09, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K946274	COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN	Jul 11, 1995	Substantially Equivalent	Helena Laboratories
K936285	ABBOTT VISION GLYCATED HB, MODIFICATION	Jun 09, 1995	Substantially Equivalent	Abbott Laboratories
K951361	DCA 2000 SYSTEM FOR HEMOGLOBIN A1C	May 05, 1995	Substantially Equivalent	Heraeus Kulzer, Inc.
K941616	VARIANT TOTAL GHB PROGRAM	Apr 14, 1995	Substantially Equivalent	Bio-Rad
K934070	TINA-QUANT HEMOGLOBIN A1C	Oct 11, 1994	Substantially Equivalent	Boehringer Mannheim Corp.
K942009	PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY	Sep 14, 1994	Substantially Equivalent	Primus Corp.
K940971	AMES DCA 2000 HEMOGLOBIN ALC CONTROLS	Jul 19, 1994	Substantially Equivalent	Heraeus Kulzer, Inc.
K935613	RADIAS MONOCLONAL HBA 1C ASSAY	Apr 05, 1994	Substantially Equivalent	Bio-Rad
K936204	GLYCATED HEMOGLOBIN CALIBRATORS	Mar 22, 1994	Substantially Equivalent	Primus Corp.
K940143	GLYCATED HEMOGLOBIN CONTROLS	Mar 15, 1994	Substantially Equivalent	Primus Corp.
K931183	GLYCOHEMOGLOBIN	Nov 05, 1993	Substantially Equivalent	Teco Diagnostics
K933287	745 GLYCOMAT	Sep 09, 1993	Substantially Equivalent	Drew Scientific , Ltd.
K930823	PROTEIN-BOUND GLUCOSE ASSAYN KIT	Aug 19, 1993	Substantially Equivalent	Diagnostic Specialties
K926469	VARIANT(TM) HEMOGLOBIN A 1C PROGRAM	Mar 29, 1993	Substantially Equivalent	Bio-Rad
K925204	BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED	Jan 12, 1993	Substantially Equivalent	Beckman Instruments, Inc.
K921831	IMX(R) GLYCATED HEMOGLOBIN	Sep 29, 1992	Substantially Equivalent	Abbott Laboratories
K920820	MODIFICATION COLUMNMATE	Aug 17, 1992	Substantially Equivalent	Helena Laboratories
K920397	REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT	Aug 04, 1992	Substantially Equivalent	Medical Analysis Systems, Inc.
K920449	POINTE 750 GLYCOMETER	Jul 28, 1992	Substantially Equivalent	Pointe Scientific, Inc.,
K920198	GLYCOMAT HAEMOGLOBIN ANALYSER	Jul 21, 1992	Substantially Equivalent	Drew Scientific , Ltd.
K921676	COLUMNMATE II	Jul 10, 1992	Substantially Equivalent	Helena Laboratories
K921305	GLYCO-TEK AFFINITY COLUMN KIT	Jun 09, 1992	Substantially Equivalent	Helena Laboratories
K913614	FRUCTOSAMINE ABG21 TEST SYSTEM	Dec 02, 1991	Substantially Equivalent	Boehringer Mannheim Corp.
K912748	BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT	Oct 31, 1991	Substantially Equivalent	Binax, Inc.
K905709	BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT	Sep 23, 1991	Substantially Equivalent	Beckman Instruments, Inc.
K911625	AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM	Sep 05, 1991	Substantially Equivalent	Heraeus Kulzer, Inc.
K904027	ABBOTT VISION(TM) GLYCATED HB	Feb 07, 1991	Substantially Equivalent	Abbott Laboratories
K905513	GLYC-AFFIN(TM)-GA	Jan 15, 1991	Substantially Equivalent	Isolab, Inc.
K904814	GLYC-AFFIN GP	Dec 26, 1990	Substantially Equivalent	Isolab, Inc.
K896830	OPTIMATE HEMOGLOBIN A1C	Sep 11, 1990	Substantially Equivalent	Heraeus Kulzer, Inc.
K902457	ABNORMAL GLYCOHEMOGLOBIN CONTROL	Jul 24, 1990	Substantially Equivalent	Analytical Control Systems, Inc.
K902455	ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)	Jul 24, 1990	Substantially Equivalent	Analytical Control Systems, Inc.
K896582	DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)	Jun 28, 1990	Substantially Equivalent	Primus, Inc.
K901414	COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581	Jun 15, 1990	Substantially Equivalent	Helena Laboratories
K900718	ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY	Jun 12, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K896335	CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR	Dec 11, 1989	Substantially Equivalent	Creative Laboratory Products, Inc.
K896334	CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER	Dec 11, 1989	Substantially Equivalent	Creative Laboratory Products, Inc.
K895661	GLYCOTEST II GLYHB ASSAY KIT	Dec 07, 1989	Substantially Equivalent	Pierce Chemical Co.
K893453	GLYCABEN	Oct 23, 1989	Substantially Equivalent	Exocell, Inc.
K893224	REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207	Jun 20, 1989	Substantially Equivalent	Helena Laboratories
K891235	PRIMUS MODEL CLC 330	Jun 16, 1989	Substantially Equivalent	Primus, Inc.
K884184	SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE	Mar 28, 1989	Substantially Equivalent	Sigma Diagnostics, Inc.
K884315	LABILE LYSING REAGENT	Dec 27, 1988	Substantially Equivalent	Helena Laboratories
K880673	GHB SAMPLE PAPER	Nov 22, 1988	Substantially Equivalent	Isolab, Inc.
K881863	REP GLYCO SYSTEM	Sep 30, 1988	Substantially Equivalent	Helena Laboratories
K874749	BINAX EQUATE GLYCOHEMOGLOBIN	Aug 12, 1988	Substantially Equivalent	Binax, Inc.
K882222	DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY	Aug 01, 1988	Substantially Equivalent	Bio-Rad
K882051	BIO-RAD HEMOGLOBIN DETECTOR	Aug 01, 1988	Substantially Equivalent	Bio-Rad
K880698	TITAN GEL-PC GLYCO-HEME(TM) SYSTEM	May 06, 1988	Substantially Equivalent	Helena Laboratories
K873428	GLYCO-PROBE GSP	Apr 05, 1988	Substantially Equivalent	Isolab, Inc.
K875354	UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM	Feb 17, 1988	Substantially Equivalent	Ulster Scientific, Inc.
K854010	FRUCTOSAMINE TEST (ROCHE)	Dec 22, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K872852	EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST	Sep 29, 1987	Substantially Equivalent	Sandare Chemical Co., Inc.
K871679	FOCUS-GHB	Jul 28, 1987	Substantially Equivalent	Awareness Technology, Inc.
K871388	MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER	Jul 06, 1987	Substantially Equivalent	Bio-Rad
K864643	GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT	Apr 28, 1987	Substantially Equivalent	Pacific Hemostasis
K862371	HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)	Sep 16, 1986	Substantially Equivalent	Bio-Rad
K861697	SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)	Aug 19, 1986	Substantially Equivalent	Awareness Technology, Inc.
K862556	SANDARE GLYCOHEMOGLOBIN PROCEDURE	Aug 08, 1986	Substantially Equivalent	Sandare Chemical Co., Inc.
K860572	GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET	May 16, 1986	Substantially Equivalent	Pointe Scientific, Inc.,
K852986	GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN	Aug 19, 1985	Substantially Equivalent	Clinical Technology Corp.
K851636	DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM	Jul 30, 1985	Substantially Equivalent	Bio-Rad
K852111	GLYCO-CHECK	Jul 05, 1985	Substantially Equivalent	Thyroid Diagnostics, Inc.
K842689	GLYCO-TEK AFFINITY COLUMN	Oct 15, 1984	Substantially Equivalent	Helena Laboratories
K834294	ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB	Jan 24, 1984	Substantially Equivalent	Emd Chemicals, Inc.
K833772	AUTO AIC ANALYZER SYSTEM	Jan 18, 1984	Substantially Equivalent	Helena Laboratories
K833805	GLYCOGLOBIN KIT	Jan 03, 1984	Substantially Equivalent	Endocrine Sciences Products
K833356	GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL	Nov 03, 1983	Substantially Equivalent	Helena Laboratories
K832775	A-GENT GLYCOSYLATED HEMOGLOBIN	Sep 29, 1983	Substantially Equivalent	Abbott Laboratories
K832087	TITAN GEL GLYCO-HEME SYSTEM	Aug 24, 1983	Substantially Equivalent	Helena Laboratories
K831837	CLINOVATIVE II DIAGNOSTIC KIT	Aug 01, 1983	Substantially Equivalent	Pierce Chemical Co.
K831478	LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN	Jun 22, 1983	Substantially Equivalent	Bio-Rad
K830935	HEMOGLOBIN ALC BY COLUMN TEST	Jun 16, 1983	Substantially Equivalent	Bio-Rad
K823869	GLYCO HB QUIK COLUMN PROCEDURE	Feb 01, 1983	Substantially Equivalent	Helena Laboratories
K822867	GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY	Dec 03, 1982	Substantially Equivalent	Isolab, Inc.
K822977	HEMOGLOBIN ALC BY COLUMN TEST	Nov 16, 1982	Substantially Equivalent	Bio-Rad
K821360	GLYCO-GEL TEST KIT	Jun 02, 1982	Substantially Equivalent	Pierce Chemical Co.
K820279	GLYCO-GEL TEST KIT	Apr 08, 1982	Substantially Equivalent	Pierce Chemical Co.
K820076	GLYCO-SEP REAGENT TEST SET	Feb 12, 1982	Substantially Equivalent	Clin Tech Diagnostics Corp.
K811567	ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S	Sep 16, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K810958	GLYCOHEMOGLOBIN	Sep 16, 1981	Substantially Equivalent	Macomb Chemical Co.
K812242	CORDISNHYPERION HEMOGLOBIN A1 TEST SYS	Sep 09, 1981	Substantially Equivalent	Cordis Corp.
K811710	BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST	Jul 15, 1981	Substantially Equivalent	Bio-Rad
K811000	ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL	May 08, 1981	Substantially Equivalent	Corning Medical & Scientific
K810714	LANCER GLYCOSYLATED HEMOGLOBIN ASSAY	May 08, 1981	Substantially Equivalent	Sherwood Medical Co.
K810638	LANCER GLYCOSYLATED HEMOGLOBIN	May 08, 1981	Substantially Equivalent	Sherwood Medical Co.
K803186	NORMAL AND ELEVATED CONTROL FOR GLYCO.	Jan 21, 1981	Substantially Equivalent	Applied Clinical Research Laboratories
K802832	SANDARE GLYCOHEMOGLOBIN PROCEDURE	Jan 16, 1981	Substantially Equivalent	Sandare Chemical Co., Inc.
K802721	GLYCOHEMOGLOBIN IN WHOLE BLOOD	Dec 11, 1980	Substantially Equivalent	Sigma Chemical Co.
K802432	GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.	Dec 01, 1980	Substantially Equivalent	Clin Tech Diagnostics Corp.
K802233	GLYCOSYLATED HEMOGLOBIN-SMC COLUMN	Oct 10, 1980	Substantially Equivalent	Helena Laboratories
K800857	HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH	Sep 26, 1980	Substantially Equivalent	Helena Laboratories
K801561	GLYCOSYLATED HEMOGLOBIN KIT	Aug 12, 1980	Substantially Equivalent	Amersham Corp.
K801422	SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.	Jul 08, 1980	Substantially Equivalent	Sandare Chemical Co., Inc.
K801289	LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT	Jun 30, 1980	Substantially Equivalent	Leeco Diagnostics, Inc.
K800794	FAST HEMOGLOBIN CONTROL-LYOPHILIZED	Apr 29, 1980	Substantially Equivalent	Isolab, Inc.
K792086	GLYCO-SPIN	Nov 30, 1979	Substantially Equivalent	Applied Clinical Research Laboratories
K791777	CORNING GLYCOSYLATED HEMOGLOBIN SET	Nov 13, 1979	Substantially Equivalent	Corning Medical & Scientific
K791642	A-GENT GLYCOSPEC	Oct 17, 1979	Substantially Equivalent	Abbott Laboratories
K791365	FAST FLOW #60310	Sep 27, 1979	Substantially Equivalent	Hi Chem, Inc.
K791428	GLUCOHEMOGLOBIN CONTROL	Aug 22, 1979	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K791135	LYOPHILIZED G-HB QUIK COLUMN CONTROL	Jun 28, 1979	Substantially Equivalent	Helena Laboratories
K791103	LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT	Jun 28, 1979	Substantially Equivalent	Leeco Diagnostics, Inc.
K790583	QUIK COLUMN METHODOLOGY	Apr 23, 1979	Substantially Equivalent	Helena Laboratories
K790046	G-HB QUIK COLUMN CONTROL	Jan 26, 1979	Substantially Equivalent	Helena Laboratories
K781948	COLUMN TEST, HEMOGLOBIN A	Dec 20, 1978	Substantially Equivalent	Bio-Rad
K781851	HEMOGLOBIN, TESTING SYSTEM	Nov 07, 1978	Substantially Equivalent	Isolab, Inc.
K780819	GLYCOHEMOGLOBIN-SKREEN TEST KIT	Nov 07, 1978	Substantially Equivalent	Eppendorf-Brinkmann, Inc.
K780573	TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN	Nov 07, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic