AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10— 510(k) K974053

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K974053 for AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10, Substantially Equivalent on 1997-12-08. Applicant: Diagnostic Chemicals , Ltd..

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1997-10-27
Decision date: 1997-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

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