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 03, 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411
Microgenics Corp.
Chemistry · 58d
Cleared Jan 20, 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001
Bio-Rad Laboratories, Inc.
Chemistry · 17d
Cleared Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
K052464
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Aug 08, 2005
HEMOGLOBIN A1C REAGENT SET
K051200
Teco Diagnostics
Toxicology · 90d
Cleared Jul 22, 2005
AFINION HBALC
K050574
Axis-Shield Poc AS
Chemistry · 137d
Cleared Jun 28, 2005
HBA1C ENZYMATIC ASSAY
K050178
General Atomics
Chemistry · 153d
Cleared Jun 13, 2005
INVIEW
K051321
Metrika, Inc.
Chemistry · 24d
Cleared Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459
Beckman Coulter, Inc.
Chemistry · 68d
Cleared Oct 29, 2004
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
K042193
Diazyme Laboratories
Chemistry · 78d
Cleared Oct 15, 2004
LIQUI-HEME GLYCO A1C ASSAY
K031296
Biodiagnostic Intl
Chemistry · 541d
Cleared Sep 09, 2004
THE VITROS 5,1 FS CHEMISTRY SYSTEM
K041764
Ortho-Clinical Diagnostics
Chemistry · 71d
Cleared Aug 16, 2004
G5 I HBA1C TEST, G5 II HBA1C TEST
K041635
Provalis Diagnostics , Ltd.
Chemistry · 61d
Cleared Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
K041444
Bio-Rad Laboratories, Inc.
Chemistry · 8d
Cleared Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
K040872
Bio-Rad Laboratories, Inc.
Chemistry · 13d
Cleared Feb 09, 2004
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674
Seradyn, Inc.
Chemistry · 77d
Cleared Dec 23, 2003
A1CNOW FOR HOME AND PROFESSIONAL USE
K033847
Metrika, Inc.
Chemistry · 12d
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 Dec 13, 2002
A1CNOW FOR HOME USE
K022661
Metrika, Inc.
Hematology · 126d