UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50— 510(k) K993178

Name: FDA 510(k) clearance K993178
Creator: U.S. Food and Drug Administration
Published: 1999-10-18

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K993178 for UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50, Substantially Equivalent on 1999-10-18. 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: 1999-09-23
Decision date: 1999-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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