BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02— 510(k) K861094

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K861094 for BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02, Substantially Equivalent on 1986-04-21. Applicant: Diagnostic Chemicals, Ltd. (Usa).

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1986-03-24
Decision date: 1986-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

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