UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30— 510(k) K002694

Name: FDA 510(k) clearance K002694
Creator: U.S. Food and Drug Administration
Published: 2000-09-15

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K002694 for UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30, Substantially Equivalent on 2000-09-15. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 2000-08-29
Decision date: 2000-09-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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