ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30— 510(k) K980316

Name: FDA 510(k) clearance K980316
Creator: U.S. Food and Drug Administration
Published: 1998-02-12

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K980316 for ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30, Substantially Equivalent on 1998-02-12. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1998-01-27
Decision date: 1998-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

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