RANDOX AMPHETAMINE CLASS ASSAY— 510(k) K040350

Name: FDA 510(k) clearance K040350
Creator: U.S. Food and Drug Administration
Published: 2004-05-12

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K040350 for RANDOX AMPHETAMINE CLASS ASSAY, Substantially Equivalent on 2004-05-12. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2004-02-12
Decision date: 2004-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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