AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10— 510(k) K033921

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K033921 for AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10, Substantially Equivalent on 2004-03-10. Applicant: Diagnostic Chemicals , Ltd..

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code JIF
Advisory panel: Clinical Chemistry
Date received: 2003-12-18
Decision date: 2004-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

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