RANDOX ETHANOL ASSAY— 510(k) K092273

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K092273 for RANDOX ETHANOL ASSAY, Substantially Equivalent on 2010-11-01. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DIC
Advisory panel: Clinical Toxicology
Date received: 2009-07-28
Decision date: 2010-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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