PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30— 510(k) K974858

Name: FDA 510(k) clearance K974858
Creator: U.S. Food and Drug Administration
Published: 1998-01-30

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K974858 for PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30, Substantially Equivalent on 1998-01-30. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1997-12-29
Decision date: 1998-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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