ENZYMATIC CREATININE ASSAY (265 SERIES)— 510(k) K070383

Name: FDA 510(k) clearance K070383
Creator: U.S. Food and Drug Administration
Published: 2007-06-22

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K070383 for ENZYMATIC CREATININE ASSAY (265 SERIES), Substantially Equivalent on 2007-06-22. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2007-02-09
Decision date: 2007-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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