VITAL SERUM CONTROLS


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K111063
Device Name VITAL SERUM CONTROLS
Applicant
VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD.
189-190 browns road
noble park victoria, 

AT

3174

Applicant Contact melita lambiris
Correspondent
VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD.
189-190 browns road
noble park victoria, 

AT

3174

Correspodent Contact melita lambiris
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 04/18/2011
Decision Date 06/28/2011
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