CREATINE KINASE LIQUID REAGENT, MODEL C519-440


Device Classification Name

nad reduction/nadh oxidation, cpk or isoenzymes

510(k) Number K072548
Device Name CREATINE KINASE LIQUID REAGENT, MODEL C519-440
Applicant
TECO DIAGNOSTICS
1268 north lakeview ave.
anaheim, 
CA 
92807

Applicant Contact kelly chen
Correspondent
TECO DIAGNOSTICS
1268 north lakeview ave.
anaheim, 
CA 
92807

Correspodent Contact kelly chen
Regulation Number 862.1215
Classification Product Code
CGS  
Date Received 09/10/2007
Decision Date 04/18/2008
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