RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3— 510(k) K121603

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K121603 for RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3, Substantially Equivalent on 2012-11-20. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2012-04-06
Decision date: 2012-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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