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 Jan 20, 2011
TQ HBA1C GEN3
K102914
Roche
Chemistry · 111d
Cleared Aug 27, 2010
ST AIA PACK HBA1C
K100304
Tosoh Bioscience, Inc.
Chemistry · 205d
Cleared Jan 14, 2010
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
K082275
Infopia Co, Ltd.
Chemistry · 521d
Cleared Dec 11, 2009
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 184d
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 Jun 11, 2009
MODIFICATION TO AVIE A1C TEST SYSTEM
K091400
Mec Dynamics Corp
Chemistry · 30d
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 Mar 20, 2009
AVIE A1C TEST SYSTEM
K081269
Mec Dynamics Corp
Chemistry · 319d
Cleared Jan 08, 2009
ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
K081895
Siemens Medical Solutions Diagnostics
Chemistry · 189d
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 Nov 26, 2007
PRIMUS A1CARE ASSAY
K062658
Primus Corp.
Chemistry · 446d
Cleared Oct 09, 2007
DCA VANTAGE, MODEL 5075
K071466
Siemens Medical Solutions Diagnostics
Chemistry · 133d
Cleared Jun 25, 2007
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
K070819
Bio-Rad Laboratories Inc., Clinical Systems Divisi
Chemistry · 91d
Cleared May 07, 2007
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared Apr 17, 2007
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
K063306
Alfa Wassermann, Inc.
Chemistry · 167d
Cleared Apr 09, 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
K070734
Diazyme Laboratories
Chemistry · 24d
Cleared Mar 21, 2007
HBA1C
K063209
Thermo Electron OY
Chemistry · 149d
Cleared Dec 27, 2006
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
K063643
Bio-Rad Laboratories Inc., Clinical Systems Divisi
Chemistry · 20d
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