TINA-QUANT HBA1C GEN.2


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K110313
Device Name TINA-QUANT HBA1C GEN.2
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250

Applicant Contact susan hollandbeck
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250

Correspodent Contact susan hollandbeck
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 02/02/2011
Decision Date 12/23/2011
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