RANDOX IMMUNOASSAY CONTROL— 510(k) K040379

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K040379 for RANDOX IMMUNOASSAY CONTROL, Substantially Equivalent on 2004-06-16. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2004-02-17
Decision date: 2004-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.