LCP · Class II · 21 CFR 864.7470

FDA Product Code LCP: Assay, Glycosylated Hemoglobin

Leading manufacturers include Helena Laboratories, Bio-Rad and Bio-Rad Laboratories, Inc..

249
Total
249
Cleared
146d
Avg days
1978
Since
249 devices
97–120 of 249
Cleared Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
K021897
Randox Laboratories, Ltd.
Chemistry · 169d
Cleared Jun 14, 2002
HEMOGLOBIN A1C CONTROL
K021484
Canterbury Scientific , Ltd.
Hematology · 37d
Cleared Apr 24, 2002
POLYMEDCO HBA1C TEST
K020532
Polymedco, Inc.
Hematology · 64d
Cleared Feb 15, 2002
A1CNOW FOR RX HOME USE
K020234
Metrika, Inc.
Hematology · 23d
Cleared Feb 15, 2002
A1CNOW FOR PROFESSIONAL USE
K020235
Metrika, Inc.
Hematology · 23d
Cleared Jan 22, 2002
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K013465
Diabetes Technologies, Inc.
Hematology · 96d
Cleared Nov 15, 2001
DIMENSION HAIC ASSAY, MODEL DF105
K011852
Dade Behring, Inc.
Chemistry · 156d
Cleared Nov 02, 2001
GLYCOSAL II HBA 1C TEST
K011933
Provalis Diagnostics , Ltd.
Chemistry · 135d
Cleared Oct 26, 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410
Sigma Diagnostics, Inc.
Hematology · 88d
Cleared Oct 04, 2001
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
K012525
Thermo Dma, Inc.
Chemistry · 59d
Cleared Sep 18, 2001
G7 AUTOMATED HPLC ANALYZER
K011434
Tosoh Medics, Inc.
Hematology · 131d
Cleared Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748
Beckman Coulter, Inc.
Hematology · 119d
Cleared Dec 19, 2000
VARIANT II TOTAL GHB
K003280
Bio-Rad
Hematology · 61d
Cleared Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120
Roche Diagnostics Corp.
Hematology · 74d
Cleared Sep 26, 2000
DRX HBA1C - FOR PRESCRIPTION HOME USE
K000885
Metrika, Inc.
Hematology · 190d
Cleared Aug 21, 2000
GLYCOSAL HBA1C TEST
K001392
Provalis Diagnostics , Ltd.
Hematology · 110d
Cleared Jul 26, 2000
DRX HBA1C
K000887
Metrika, Inc.
Hematology · 128d
Cleared May 25, 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085
Abbott Laboratories
Hematology · 339d
Cleared May 22, 2000
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
K993131
Primus, Inc.
Hematology · 245d
Cleared Mar 21, 2000
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K000239
Genzyme Corp.
Hematology · 54d
Cleared Dec 21, 1999
HEMOCHEK-A1C SAMPLE COLLECTION KIT
K990899
Osborn Group, Inc.
Hematology · 278d
Cleared Dec 21, 1999
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
K993590
Pointe Scientific, Inc.,
Chemistry · 60d
Cleared Dec 21, 1999
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
K994045
Primus Corp.
Hematology · 22d
Cleared Dec 16, 1999
FRUCTOSAMINE, MODEL FR 106-01
K991246
A.P. Total Care, Inc.
Chemistry · 248d