RANDOX URINE CONTROLS— 510(k) K043266

Name: FDA 510(k) clearance K043266
Creator: U.S. Food and Drug Administration
Published: 2005-02-15

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K043266 for RANDOX URINE CONTROLS, Substantially Equivalent on 2005-02-15. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2004-11-26
Decision date: 2005-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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