RANDOX OPIATES ASSAY— 510(k) K113747

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K113747 for RANDOX OPIATES ASSAY, Substantially Equivalent on 2012-08-24. Applicant: Randox Laboratories Limited.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2011-12-20
Decision date: 2012-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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