DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270


Device Classification Name

enzymatic method, creatinine

510(k) Number K073055
Device Name DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
Applicant
DADE BEHRING, INC.
p.o. box 6101
ms 514
newark, 
DE 
19714

Applicant Contact victor m carrio
Correspondent
DADE BEHRING, INC.
p.o. box 6101
ms 514
newark, 
DE 
19714

Correspodent Contact victor m carrio
Regulation Number 862.1225
Classification Product Code
JFY  
Date Received 10/30/2007
Decision Date 01/03/2008
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

Recalls CDRH Recalls