CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30— 510(k) K973999

Name: FDA 510(k) clearance K973999
Creator: U.S. Food and Drug Administration
Published: 1998-03-11

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K973999 for CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30, Substantially Equivalent on 1998-03-11. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1997-10-21
Decision date: 1998-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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