CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K080607
Device Name CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50416
indianapolis, 
IN 
46250 -3831

Applicant Contact kathie j cunningham
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50416
indianapolis, 
IN 
46250 -3831

Correspodent Contact kathie j cunningham
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 03/04/2008
Decision Date 05/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No