TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K072714
Device Name TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact theresa a bush
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact theresa a bush
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 09/25/2007
Decision Date 04/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No