ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS


Device Classification Name

nadh oxidation/nad reduction, ast/sgot

510(k) Number K080485
Device Name ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
Applicant
DIASYS DIAGNOSTICS SYSTEMS GMBH
alte strasse 9
holzheim, rheinland-pfalz, 

DE

d-65558

Applicant Contact stephanie klein
Correspondent
DIASYS DIAGNOSTICS SYSTEMS GMBH
alte strasse 9
holzheim, rheinland-pfalz, 

DE

d-65558

Correspodent Contact stephanie klein
Regulation Number 862.1100
Classification Product Code
CIT  
Subsequent Product Codes
JIT   JJX  
Date Received 02/22/2008
Decision Date 12/04/2008
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