BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30— 510(k) K023330

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K023330 for BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30, Substantially Equivalent on 2002-12-11. Applicant: Diagnostic Chemicals , Ltd..

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 2002-10-04
Decision date: 2002-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

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