VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K122472
Device Name VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
Applicant
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
4000 alfred nobel drive
hercules, 
CA 
94547

Applicant Contact jackie buckley
Correspondent
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
4000 alfred nobel drive
hercules, 
CA 
94547

Correspodent Contact jackie buckley
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 08/14/2012
Decision Date 10/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No