ATAC TOTAL BILIRUBIN REAGENT— 510(k) K030014

Substantially Equivalent

Elan Diagnostics

FDA 510(k) clearance K030014 for ATAC TOTAL BILIRUBIN REAGENT, Substantially Equivalent on 2003-09-26. Applicant: Elan Diagnostics.

Clearance details

Applicant: Elan Diagnostics
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 2003-01-02
Decision date: 2003-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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