TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50— 510(k) K973108

Name: FDA 510(k) clearance K973108
Creator: U.S. Food and Drug Administration
Published: 1998-03-02

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K973108 for TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50, Substantially Equivalent on 1998-03-02. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1997-08-19
Decision date: 1998-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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