ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)— 510(k) K110394

Substantially Equivalent

Vital Diagnostics (Manufacturing) Ptyltd

FDA 510(k) clearance K110394 for ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON), Substantially Equivalent on 2011-06-09. Applicant: Vital Diagnostics (Manufacturing) Ptyltd.

Clearance details

Applicant: Vital Diagnostics (Manufacturing) Ptyltd
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2011-02-11
Decision date: 2011-06-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Noble Park, AU

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