COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY


Device Classification Name

hemoglobin a1c test system

510(k) Number K121610
Device Name COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
Applicant
ROCHE DIAGNOSTICS OPERATIONS
9115 hague rd
indianapolis, 
IN 
46256

Applicant Contact susan hollandbeck
Correspondent
ROCHE DIAGNOSTICS OPERATIONS
9115 hague rd
indianapolis, 
IN 
46256

Correspodent Contact susan hollandbeck
Regulation Number 862.1373
Classification Product Code
PDJ  
Date Received 06/01/2012
Decision Date 08/08/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No