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
25–48 of 249
Cleared May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
K090413
Bayer Healthcare, LLC
Chemistry · 85d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714
Roche Diagnostics Corp.
Chemistry · 206d
Cleared May 07, 2007
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared Apr 09, 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
K070734
Diazyme Laboratories
Chemistry · 24d
Cleared Dec 01, 2006
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400
Bio-Rad Laboratories, Inc.
Chemistry · 22d
Cleared Apr 06, 2006
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
K060650
Ortho-Clinical Diagnostics, Inc.
Chemistry · 24d
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 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 Sep 09, 2004
THE VITROS 5,1 FS CHEMISTRY SYSTEM
K041764
Ortho-Clinical Diagnostics
Chemistry · 71d
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 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 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 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 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