| A1CNOW FOR RX HOME USE (K020234) | Metrika, Inc. | 2002-02-15 |
| ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT (K013465) | Diabetes Technologies, Inc. | 2002-01-22 |
| DIMENSION HAIC ASSAY, MODEL DF105 (K011852) | Dade Behring, Inc. | 2001-11-15 |
| GLYCOSAL II HBA 1C TEST (K011933) | Provalis Diagnostics , Ltd. | 2001-11-02 |
| INFINITY HBA KIT, MODELS 537-A, 537-B (K012410) | Sigma Diagnostics, Inc. | 2001-10-26 |
| THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 (K012525) | Thermo Dma, Inc. | 2001-10-04 |
| G7 AUTOMATED HPLC ANALYZER (K011434) | Tosoh Medics, Inc. | 2001-09-18 |
| SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT (K010748) | Beckman Coulter, Inc. | 2001-07-10 |
| VARIANT II TOTAL GHB (K003280) | Bio-Rad | 2000-12-19 |
| MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C (K003120) | Roche Diagnostics Corp. | 2000-12-18 |
| DRX HBA1C - FOR PRESCRIPTION HOME USE (K000885) | Metrika, Inc. | 2000-09-26 |
| GLYCOSAL HBA1C TEST (K001392) | Provalis Diagnostics , Ltd. | 2000-08-21 |
| DRX HBA1C (K000887) | Metrika, Inc. | 2000-07-26 |
| ABBOTT IMX GLYCATED HEMOGLOBIN II (K992085) | Abbott Laboratories | 2000-05-25 |
| NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY (K993131) | Primus, Inc. | 2000-05-22 |
| GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (K000239) | Genzyme Corp. | 2000-03-21 |
| HEMOCHEK-A1C SAMPLE COLLECTION KIT (K990899) | Osborn Group, Inc. | 1999-12-21 |
| FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET (K993590) | Pointe Scientific, Inc., | 1999-12-21 |
| PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 (K994045) | Primus Corp. | 1999-12-21 |
| FRUCTOSAMINE, MODEL FR 106-01 (K991246) | A.P. Total Care, Inc. | 1999-12-16 |
| SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC (K991850) | Biosafe Laboratories, Inc. | 1999-11-26 |
| PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II (K992921) | Primus Corp. | 1999-11-12 |
| ABBOTT ARCHITECT GLYCATED HEMOGLOBIN (K991483) | Abbott Laboratories | 1999-11-01 |
| INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC (K990992) | Roche Diagnostics Corp. | 1999-09-30 |
| HEMOCHEK SAMPLE COLLECTION KIT (K984529) | Osborn Laboratories, Inc. | 1999-01-28 |
| VARIANT II HEMOGLOBIN A1C PROGRAM (K984268) | Bio-Rad | 1998-12-17 |
| ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT (K983172) | Diabetes Technologies, Inc. (Dti) | 1998-11-30 |
| GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (K983726) | Genzyme Corp. | 1998-11-25 |
| PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT (K983253) | Medisense, Inc. | 1998-11-20 |
| GLYCACOR (K980888) | Exocell, Inc. | 1998-08-13 |
| AIC - CHEK (HBAIC-I) (K973365) | Express-Med, Inc. | 1998-06-15 |
| ACCU-CHEK A1C HEMOGLOBIN TEST (K974491) | Boehringer Mannheim Corp. | 1998-05-13 |
| SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT (K973696) | Beckman Instruments, Inc. | 1997-11-24 |
| A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER (K972265) | Tosoh Medics, Inc. | 1997-09-25 |
| EZCHEK/HBA BLOOD COLLECTION KIT (K971919) | Flexsite Diagnostics, Inc. | 1997-09-05 |
| LXN FRUCTOSAMINE TEST SYSTEM (K962597) | Lxn Corp. | 1997-06-13 |
| HYDRAGEL 15 HB A1C KIT (K963844) | Morax | 1997-04-22 |
| ROCHE UNIMATE FRUCTOSAMINE REAGENT (K961674) | Roche Diagnostic Systems, Inc. | 1996-09-27 |
| HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K955087) | Bayer Corp. | 1996-06-13 |
| ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P (K952337) | Roche Diagnostic Systems, Inc. | 1996-02-09 |
| COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN (K946274) | Helena Laboratories | 1995-07-11 |
| ABBOTT VISION GLYCATED HB, MODIFICATION (K936285) | Abbott Laboratories | 1995-06-09 |
| DCA 2000 SYSTEM FOR HEMOGLOBIN A1C (K951361) | Heraeus Kulzer, Inc. | 1995-05-05 |
| VARIANT TOTAL GHB PROGRAM (K941616) | Bio-Rad | 1995-04-14 |
| TINA-QUANT HEMOGLOBIN A1C (K934070) | Boehringer Mannheim Corp. | 1994-10-11 |
| PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY (K942009) | Primus Corp. | 1994-09-14 |
| AMES DCA 2000 HEMOGLOBIN ALC CONTROLS (K940971) | Heraeus Kulzer, Inc. | 1994-07-19 |
| RADIAS MONOCLONAL HBA 1C ASSAY (K935613) | Bio-Rad | 1994-04-05 |
| GLYCATED HEMOGLOBIN CALIBRATORS (K936204) | Primus Corp. | 1994-03-22 |
| GLYCATED HEMOGLOBIN CONTROLS (K940143) | Primus Corp. | 1994-03-15 |
| GLYCOHEMOGLOBIN (K931183) | Teco Diagnostics | 1993-11-05 |
| 745 GLYCOMAT (K933287) | Drew Scientific , Ltd. | 1993-09-09 |
| PROTEIN-BOUND GLUCOSE ASSAYN KIT (K930823) | Diagnostic Specialties | 1993-08-19 |
| VARIANT(TM) HEMOGLOBIN A 1C PROGRAM (K926469) | Bio-Rad | 1993-03-29 |
| BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED (K925204) | Beckman Instruments, Inc. | 1993-01-12 |
| IMX(R) GLYCATED HEMOGLOBIN (K921831) | Abbott Laboratories | 1992-09-29 |
| MODIFICATION COLUMNMATE (K920820) | Helena Laboratories | 1992-08-17 |
| REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT (K920397) | Medical Analysis Systems, Inc. | 1992-08-04 |
| POINTE 750 GLYCOMETER (K920449) | Pointe Scientific, Inc., | 1992-07-28 |
| GLYCOMAT HAEMOGLOBIN ANALYSER (K920198) | Drew Scientific , Ltd. | 1992-07-21 |
| COLUMNMATE II (K921676) | Helena Laboratories | 1992-07-10 |
| GLYCO-TEK AFFINITY COLUMN KIT (K921305) | Helena Laboratories | 1992-06-09 |
| FRUCTOSAMINE ABG21 TEST SYSTEM (K913614) | Boehringer Mannheim Corp. | 1991-12-02 |
| BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT (K912748) | Binax, Inc. | 1991-10-31 |
| BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT (K905709) | Beckman Instruments, Inc. | 1991-09-23 |
| AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM (K911625) | Heraeus Kulzer, Inc. | 1991-09-05 |
| ABBOTT VISION(TM) GLYCATED HB (K904027) | Abbott Laboratories | 1991-02-07 |
| GLYC-AFFIN(TM)-GA (K905513) | Isolab, Inc. | 1991-01-15 |
| GLYC-AFFIN GP (K904814) | Isolab, Inc. | 1990-12-26 |
| OPTIMATE HEMOGLOBIN A1C (K896830) | Heraeus Kulzer, Inc. | 1990-09-11 |
| ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) (K902455) | Analytical Control Systems, Inc. | 1990-07-24 |
| ABNORMAL GLYCOHEMOGLOBIN CONTROL (K902457) | Analytical Control Systems, Inc. | 1990-07-24 |
| DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) (K896582) | Primus, Inc. | 1990-06-28 |
| COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 (K901414) | Helena Laboratories | 1990-06-15 |
| ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY (K900718) | Roche Diagnostic Systems, Inc. | 1990-06-12 |
| CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER (K896334) | Creative Laboratory Products, Inc. | 1989-12-11 |
| CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR (K896335) | Creative Laboratory Products, Inc. | 1989-12-11 |
| GLYCOTEST II GLYHB ASSAY KIT (K895661) | Pierce Chemical Co. | 1989-12-07 |
| GLYCABEN (K893453) | Exocell, Inc. | 1989-10-23 |
| REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 (K893224) | Helena Laboratories | 1989-06-20 |
| PRIMUS MODEL CLC 330 (K891235) | Primus, Inc. | 1989-06-16 |
| SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE (K884184) | Sigma Diagnostics, Inc. | 1989-03-28 |
| LABILE LYSING REAGENT (K884315) | Helena Laboratories | 1988-12-27 |
| GHB SAMPLE PAPER (K880673) | Isolab, Inc. | 1988-11-22 |
| REP GLYCO SYSTEM (K881863) | Helena Laboratories | 1988-09-30 |
| BINAX EQUATE GLYCOHEMOGLOBIN (K874749) | Binax, Inc. | 1988-08-12 |
| DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY (K882222) | Bio-Rad | 1988-08-01 |
| BIO-RAD HEMOGLOBIN DETECTOR (K882051) | Bio-Rad | 1988-08-01 |
| TITAN GEL-PC GLYCO-HEME(TM) SYSTEM (K880698) | Helena Laboratories | 1988-05-06 |
| GLYCO-PROBE GSP (K873428) | Isolab, Inc. | 1988-04-05 |
| UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (K875354) | Ulster Scientific, Inc. | 1988-02-17 |
| FRUCTOSAMINE TEST (ROCHE) (K854010) | Roche Diagnostic Systems, Inc. | 1987-12-22 |
| EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST (K872852) | Sandare Chemical Co., Inc. | 1987-09-29 |
| FOCUS-GHB (K871679) | Awareness Technology, Inc. | 1987-07-28 |
| MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER (K871388) | Bio-Rad | 1987-07-06 |
| GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT (K864643) | Pacific Hemostasis | 1987-04-28 |
| HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) (K862371) | Bio-Rad | 1986-09-16 |
| SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) (K861697) | Awareness Technology, Inc. | 1986-08-19 |
| SANDARE GLYCOHEMOGLOBIN PROCEDURE (K862556) | Sandare Chemical Co., Inc. | 1986-08-08 |
| GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET (K860572) | Pointe Scientific, Inc., | 1986-05-16 |