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 Jun 25, 2014
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
K140801
Bio-Rad Laboratories, Inc.
Chemistry · 86d
Cleared Apr 04, 2014
A1C GEAR SYSTEM
K130014
Sakae Corporation
Chemistry · 457d
Cleared Mar 28, 2014
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
K133344
Sebia
Chemistry · 149d
Cleared Jan 24, 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared May 09, 2013
VARIANT(TM) II TURBO HBA1C KIT - 2.0
K130990
Bio-Rad Laboratories, Inc., Clinical Systems Divis
Chemistry · 29d
Cleared Apr 25, 2013
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
K130860
Bio-Rad Laboratories, Inc., Clinical Systems Divis
Chemistry · 28d
Cleared Dec 12, 2012
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
K121842
Axis-Shield Diagnostics, Ltd.
Chemistry · 170d
Cleared Dec 06, 2012
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
K122101
Sebia
Chemistry · 143d
Cleared Oct 26, 2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472
Bio-Rad Laboratories, Inc., Clinical Systems Divis
Chemistry · 73d
Cleared Oct 12, 2012
GLYCOSYLATED HEMOGLOBIN ASSAY
K120199
Beckman Coulter, Inc.
Chemistry · 263d
Cleared Sep 13, 2012
LABONACHECK A1C
K111128
Ceragem International, Inc.
Chemistry · 511d
Cleared Sep 11, 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492
Beckman Coulter, Inc.
Chemistry · 113d
Cleared Sep 07, 2012
HEMOCUE HBA1C 501
K121366
Infopia Co, Ltd.
Chemistry · 123d
Cleared Aug 06, 2012
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
K113437
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 259d
Cleared May 14, 2012
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
K120497
Medica Corp.
Chemistry · 83d
Cleared Dec 23, 2011
TINA-QUANT HBA1C GEN.2
K110313
Roche Diagnostics
Chemistry · 324d
Cleared Nov 22, 2011
PREMIER HB9210 HBA1C ANALYZER
K112015
Primus Corporation Dba Trinity Biotech
Chemistry · 132d
Cleared Aug 25, 2011
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
K110934
Siemens Healthcare Diagnostics
Chemistry · 143d
Cleared May 17, 2011
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
K110188
Diazyme Laboratories
Chemistry · 113d
Cleared May 13, 2011
DIMENSIONS HB1C KIT, MODEL DF105A
K102510
Siemens Healthcare Diagnostics
Chemistry · 259d
Cleared Feb 15, 2011
AFINION ANALYZER
K110056
Axis-Shield Poc AS
Chemistry · 36d
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