ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12— 510(k) K974002

Name: FDA 510(k) clearance K974002
Creator: U.S. Food and Drug Administration
Published: 1998-04-01

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K974002 for ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12, Substantially Equivalent on 1998-04-01. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1997-10-21
Decision date: 1998-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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