RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3— 510(k) K130337

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K130337 for RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3, Substantially Equivalent on 2013-06-19. Applicant: Randox Laboratories Limited.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2013-02-11
Decision date: 2013-06-19
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.