CPK REAGENT


Device Classification Name

nad reduction/nadh oxidation, cpk or isoenzymes

510(k) Number K112416
Device Name CPK REAGENT
Applicant
VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD
189-199 browns road
noble park, victoria, 

AU

3174

Applicant Contact melita lambiris
Correspondent
VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD
189-199 browns road
noble park, victoria, 

AU

3174

Correspodent Contact melita lambiris
Regulation Number 862.1215
Classification Product Code
CGS  
Date Received 08/22/2011
Decision Date 11/09/2011
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