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
73–96 of 249
Cleared Feb 09, 2004
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674
Seradyn, Inc.
Chemistry · 77d
Cleared Nov 14, 2003
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
K031380
Olympus America, Inc.
Chemistry · 197d
Cleared Nov 03, 2003
ATAC HEMOGLOBIN A1C REAGENT KIT
K031042
Clinical Data, Inc.
Chemistry · 216d
Cleared Sep 02, 2003
ARKIT HBA1C
K030553
Arkray, Inc.
Chemistry · 193d
Cleared Aug 27, 2003
D-10 HEMOGLOBIN A1C
K031043
Bio-Rad Laboratories, Inc.
Chemistry · 148d
Cleared Aug 06, 2003
HEMOGLOBIN A1C REAGENT SET
K031539
Pointe Scientific, Inc.,
Chemistry · 82d
Cleared May 02, 2003
GLYCA-DIRECT FRUCTOSAMINE
K023654
Polymedco, Inc.
Chemistry · 184d
Cleared Jan 13, 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763
Randox Laboratories, Ltd.
Chemistry · 66d
Cleared Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
K021897
Randox Laboratories, Ltd.
Chemistry · 169d
Cleared Apr 24, 2002
POLYMEDCO HBA1C TEST
K020532
Polymedco, Inc.
Hematology · 64d
Cleared Nov 15, 2001
DIMENSION HAIC ASSAY, MODEL DF105
K011852
Dade Behring, Inc.
Chemistry · 156d
Cleared Oct 26, 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410
Sigma Diagnostics, Inc.
Hematology · 88d
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 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
Cleared Nov 26, 1999
SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
K991850
Biosafe Laboratories, Inc.
Hematology · 178d