S-TEST CREATININE (CRE)


Device Classification Name

enzymatic method, creatinine

510(k) Number K080073
Device Name S-TEST CREATININE (CRE)
Applicant
ALFA WASSERMANN, INC.
4 henderson dr.
west caldwell, 
NJ 
07006

Applicant Contact david slavin
Correspondent
ALFA WASSERMANN, INC.
4 henderson dr.
west caldwell, 
NJ 
07006

Correspodent Contact david slavin
Regulation Number 862.1225
Classification Product Code
JFY  
Date Received 01/11/2008
Decision Date 06/30/2008
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