LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30— 510(k) K974859

Name: FDA 510(k) clearance K974859
Creator: U.S. Food and Drug Administration
Published: 1998-01-22

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K974859 for LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30, Substantially Equivalent on 1998-01-22. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CFJ
Device class: Class 2
Regulation: 21 CFR 862.1440
Advisory panel: Clinical Chemistry
Date received: 1997-12-29
Decision date: 1998-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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