ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K110394
Device Name ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
Applicant
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
189-199 browns rd
noble park, victoria, 

AU

3174

Applicant Contact melita lambiris
Correspondent
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
189-199 browns rd
noble park, victoria, 

AU

3174

Correspodent Contact melita lambiris
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 02/11/2011
Decision Date 06/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No