RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3— 510(k) K140393

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K140393 for RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3, Substantially Equivalent on 2014-03-25. Applicant: Randox Laboratories Limited.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2014-02-14
Decision date: 2014-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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