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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020235 | A1CNOW FOR PROFESSIONAL USE | Metrika, Inc. | 2002-02-15 | Special | PDF ↗ |
| K013465 | ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT | Diabetes Technologies, Inc. | 2002-01-22 | Traditional | PDF ↗ |
| K011852 | DIMENSION HAIC ASSAY, MODEL DF105 | Dade Behring, Inc. | 2001-11-15 | Traditional | PDF ↗ |
| K011933 | GLYCOSAL II HBA 1C TEST | Provalis Diagnostics , Ltd. | 2001-11-02 | Traditional | PDF ↗ |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | Sigma Diagnostics, Inc. | 2001-10-26 | Traditional | PDF ↗ |
| K012525 | THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 | Thermo Dma, Inc. | 2001-10-04 | Abbreviated | PDF ↗ |
| K011434 | G7 AUTOMATED HPLC ANALYZER | Tosoh Medics, Inc. | 2001-09-18 | Traditional | PDF ↗ |
| K010748 | SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT | Beckman Coulter, Inc. | 2001-07-10 | Traditional | PDF ↗ |
| K003280 | VARIANT II TOTAL GHB | Bio-Rad | 2000-12-19 | Traditional | PDF ↗ |
| K003120 | MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C | Roche Diagnostics Corp. | 2000-12-18 | Traditional | PDF ↗ |
| K000885 | DRX HBA1C - FOR PRESCRIPTION HOME USE | Metrika, Inc. | 2000-09-26 | Traditional | PDF ↗ |
| K001392 | GLYCOSAL HBA1C TEST | Provalis Diagnostics , Ltd. | 2000-08-21 | Traditional | PDF ↗ |
| K000887 | DRX HBA1C | Metrika, Inc. | 2000-07-26 | Traditional | PDF ↗ |
| K992085 | ABBOTT IMX GLYCATED HEMOGLOBIN II | Abbott Laboratories | 2000-05-25 | Traditional | PDF ↗ |
| K993131 | NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY | Primus, Inc. | 2000-05-22 | Traditional | PDF ↗ |
| K000239 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | Genzyme Corp. | 2000-03-21 | Traditional | PDF ↗ |
| K994045 | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 | Primus Corp. | 1999-12-21 | Special | PDF ↗ |
| K993590 | FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET | Pointe Scientific, Inc., | 1999-12-21 | Traditional | PDF ↗ |
| K990899 | HEMOCHEK-A1C SAMPLE COLLECTION KIT | Osborn Group, Inc. | 1999-12-21 | Traditional | PDF ↗ |
| K991246 | FRUCTOSAMINE, MODEL FR 106-01 | A.P. Total Care, Inc. | 1999-12-16 | Traditional | PDF ↗ |
| K991850 | SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC | Biosafe Laboratories, Inc. | 1999-11-26 | Traditional | PDF ↗ |
| K992921 | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II | Primus Corp. | 1999-11-12 | Traditional | PDF ↗ |
| K991483 | ABBOTT ARCHITECT GLYCATED HEMOGLOBIN | Abbott Laboratories | 1999-11-01 | Traditional | PDF ↗ |
| K990992 | INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC | Roche Diagnostics Corp. | 1999-09-30 | Traditional | PDF ↗ |
| K984529 | HEMOCHEK SAMPLE COLLECTION KIT | Osborn Laboratories, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K984268 | VARIANT II HEMOGLOBIN A1C PROGRAM | Bio-Rad | 1998-12-17 | Traditional | PDF ↗ |
| K983172 | ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT | Diabetes Technologies, Inc. (Dti) | 1998-11-30 | Traditional | PDF ↗ |
| K983726 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | Genzyme Corp. | 1998-11-25 | Traditional | PDF ↗ |
| K983253 | PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT | Medisense, Inc. | 1998-11-20 | Traditional | PDF ↗ |
| K980888 | GLYCACOR | Exocell, Inc. | 1998-08-13 | Traditional | PDF ↗ |
| K973365 | AIC - CHEK (HBAIC-I) | Express-Med, Inc. | 1998-06-15 | Traditional | PDF ↗ |
| K974491 | ACCU-CHEK A1C HEMOGLOBIN TEST | Boehringer Mannheim Corp. | 1998-05-13 | Traditional | PDF ↗ |
| K973696 | SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT | Beckman Instruments, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K972265 | A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER | Tosoh Medics, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K971919 | EZCHEK/HBA BLOOD COLLECTION KIT | Flexsite Diagnostics, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K962597 | LXN FRUCTOSAMINE TEST SYSTEM | Lxn Corp. | 1997-06-13 | Traditional | PDF ↗ |
| K963844 | HYDRAGEL 15 HB A1C KIT | Morax | 1997-04-22 | Traditional | PDF ↗ |
| K961674 | ROCHE UNIMATE FRUCTOSAMINE REAGENT | Roche Diagnostic Systems, Inc. | 1996-09-27 | Traditional | PDF ↗ |
| K955087 | HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS | Bayer Corp. | 1996-06-13 | Traditional | PDF ↗ |
| K952337 | ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P | Roche Diagnostic Systems, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K946274 | COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN | Helena Laboratories | 1995-07-11 | Traditional | PDF ↗ |
| K936285 | ABBOTT VISION GLYCATED HB, MODIFICATION | Abbott Laboratories | 1995-06-09 | Traditional | PDF ↗ |
| K951361 | DCA 2000 SYSTEM FOR HEMOGLOBIN A1C | Heraeus Kulzer, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K941616 | VARIANT TOTAL GHB PROGRAM | Bio-Rad | 1995-04-14 | Traditional | PDF ↗ |
| K934070 | TINA-QUANT HEMOGLOBIN A1C | Boehringer Mannheim Corp. | 1994-10-11 | Traditional | PDF ↗ |
| K942009 | PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY | Primus Corp. | 1994-09-14 | Traditional | PDF ↗ |
| K940971 | AMES DCA 2000 HEMOGLOBIN ALC CONTROLS | Heraeus Kulzer, Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K935613 | RADIAS MONOCLONAL HBA 1C ASSAY | Bio-Rad | 1994-04-05 | Traditional | PDF ↗ |
| K936204 | GLYCATED HEMOGLOBIN CALIBRATORS | Primus Corp. | 1994-03-22 | Traditional | PDF ↗ |
| K940143 | GLYCATED HEMOGLOBIN CONTROLS | Primus Corp. | 1994-03-15 | Traditional | PDF ↗ |
| K931183 | GLYCOHEMOGLOBIN | Teco Diagnostics | 1993-11-05 | Traditional | PDF ↗ |
| K933287 | 745 GLYCOMAT | Drew Scientific , Ltd. | 1993-09-09 | Traditional | PDF ↗ |
| K930823 | PROTEIN-BOUND GLUCOSE ASSAYN KIT | Diagnostic Specialties | 1993-08-19 | Traditional | PDF ↗ |
| K926469 | VARIANT(TM) HEMOGLOBIN A 1C PROGRAM | Bio-Rad | 1993-03-29 | Traditional | PDF ↗ |
| K925204 | BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED | Beckman Instruments, Inc. | 1993-01-12 | Traditional | PDF ↗ |
| K921831 | IMX(R) GLYCATED HEMOGLOBIN | Abbott Laboratories | 1992-09-29 | Traditional | PDF ↗ |
| K920820 | MODIFICATION COLUMNMATE | Helena Laboratories | 1992-08-17 | Traditional | PDF ↗ |
| K920397 | REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT | Medical Analysis Systems, Inc. | 1992-08-04 | Traditional | PDF ↗ |
| K920449 | POINTE 750 GLYCOMETER | Pointe Scientific, Inc., | 1992-07-28 | Traditional | PDF ↗ |
| K920198 | GLYCOMAT HAEMOGLOBIN ANALYSER | Drew Scientific , Ltd. | 1992-07-21 | Traditional | PDF ↗ |
| K921676 | COLUMNMATE II | Helena Laboratories | 1992-07-10 | Traditional | PDF ↗ |
| K921305 | GLYCO-TEK AFFINITY COLUMN KIT | Helena Laboratories | 1992-06-09 | Traditional | PDF ↗ |
| K913614 | FRUCTOSAMINE ABG21 TEST SYSTEM | Boehringer Mannheim Corp. | 1991-12-02 | Traditional | PDF ↗ |
| K912748 | BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT | Binax, Inc. | 1991-10-31 | Traditional | PDF ↗ |
| K905709 | BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT | Beckman Instruments, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K911625 | AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM | Heraeus Kulzer, Inc. | 1991-09-05 | Traditional | PDF ↗ |
| K904027 | ABBOTT VISION(TM) GLYCATED HB | Abbott Laboratories | 1991-02-07 | Traditional | PDF ↗ |
| K905513 | GLYC-AFFIN(TM)-GA | Isolab, Inc. | 1991-01-15 | Traditional | PDF ↗ |
| K904814 | GLYC-AFFIN GP | Isolab, Inc. | 1990-12-26 | Traditional | PDF ↗ |
| K896830 | OPTIMATE HEMOGLOBIN A1C | Heraeus Kulzer, Inc. | 1990-09-11 | Traditional | PDF ↗ |
| K902457 | ABNORMAL GLYCOHEMOGLOBIN CONTROL | Analytical Control Systems, Inc. | 1990-07-24 | Traditional | PDF ↗ |
| K902455 | ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) | Analytical Control Systems, Inc. | 1990-07-24 | Traditional | PDF ↗ |
| K896582 | DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) | Primus, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K901414 | COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 | Helena Laboratories | 1990-06-15 | Traditional | PDF ↗ |
| K900718 | ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY | Roche Diagnostic Systems, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K896334 | CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER | Creative Laboratory Products, Inc. | 1989-12-11 | Traditional | PDF ↗ |
| K896335 | CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR | Creative Laboratory Products, Inc. | 1989-12-11 | Traditional | PDF ↗ |
| K895661 | GLYCOTEST II GLYHB ASSAY KIT | Pierce Chemical Co. | 1989-12-07 | Traditional | PDF ↗ |
| K893453 | GLYCABEN | Exocell, Inc. | 1989-10-23 | Traditional | PDF ↗ |
| K893224 | REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 | Helena Laboratories | 1989-06-20 | Traditional | PDF ↗ |
| K891235 | PRIMUS MODEL CLC 330 | Primus, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K884184 | SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE | Sigma Diagnostics, Inc. | 1989-03-28 | Traditional | PDF ↗ |
| K884315 | LABILE LYSING REAGENT | Helena Laboratories | 1988-12-27 | Traditional | PDF ↗ |
| K880673 | GHB SAMPLE PAPER | Isolab, Inc. | 1988-11-22 | Traditional | PDF ↗ |
| K881863 | REP GLYCO SYSTEM | Helena Laboratories | 1988-09-30 | Traditional | PDF ↗ |
| K874749 | BINAX EQUATE GLYCOHEMOGLOBIN | Binax, Inc. | 1988-08-12 | Traditional | PDF ↗ |
| K882222 | DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY | Bio-Rad | 1988-08-01 | Traditional | PDF ↗ |
| K882051 | BIO-RAD HEMOGLOBIN DETECTOR | Bio-Rad | 1988-08-01 | Traditional | PDF ↗ |
| K880698 | TITAN GEL-PC GLYCO-HEME(TM) SYSTEM | Helena Laboratories | 1988-05-06 | Traditional | PDF ↗ |
| K873428 | GLYCO-PROBE GSP | Isolab, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | Ulster Scientific, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K854010 | FRUCTOSAMINE TEST (ROCHE) | Roche Diagnostic Systems, Inc. | 1987-12-22 | Traditional | PDF ↗ |
| K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST | Sandare Chemical Co., Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K871679 | FOCUS-GHB | Awareness Technology, Inc. | 1987-07-28 | Traditional | PDF ↗ |
| K871388 | MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER | Bio-Rad | 1987-07-06 | Traditional | PDF ↗ |
| K864643 | GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT | Pacific Hemostasis | 1987-04-28 | Traditional | PDF ↗ |
| K862371 | HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) | Bio-Rad | 1986-09-16 | Traditional | PDF ↗ |
| K861697 | SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) | Awareness Technology, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | Sandare Chemical Co., Inc. | 1986-08-08 | Traditional | PDF ↗ |
| K860572 | GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET | Pointe Scientific, Inc., | 1986-05-16 | Traditional | PDF ↗ |
Product code LCP · Class II · Hematology. Data: openFDA.