RANDOX BARBITURATE ASSAY— 510(k) K041143

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K041143 for RANDOX BARBITURATE ASSAY, Substantially Equivalent on 2004-11-05. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DIS
Advisory panel: Clinical Toxicology
Date received: 2004-04-30
Decision date: 2004-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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