ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10— 510(k) K001286

Name: FDA 510(k) clearance K001286
Creator: U.S. Food and Drug Administration
Published: 2000-06-20

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K001286 for ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10, Substantially Equivalent on 2000-06-20. 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: 2000-04-21
Decision date: 2000-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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