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
49–72 of 249
Cleared Jul 27, 2009
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
K090699
Bio-Rad Laboratories, Inc.
Chemistry · 132d
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 Oct 17, 2008
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
K073309
Horiba Abx
Chemistry · 329d
Cleared Sep 16, 2008
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K071132
Tosoh Bioscience, Inc.
Chemistry · 512d
Cleared May 23, 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
K080618
Jas Diagnostics, Inc.
Chemistry · 79d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714
Roche Diagnostics Corp.
Chemistry · 206d
Cleared Mar 17, 2008
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686
Axis-Shield Diagnostics, Ltd.
Chemistry · 175d
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 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 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