RANDOX COCAINE METABOLITE— 510(k) K113751

Name: FDA 510(k) clearance K113751
Creator: U.S. Food and Drug Administration
Published: 2012-05-08

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K113751 for RANDOX COCAINE METABOLITE, Substantially Equivalent on 2012-05-08. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2011-12-21
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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