RANDOX CALIBRATION SERUM— 510(k) K053153

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K053153 for RANDOX CALIBRATION SERUM, Substantially Equivalent on 2006-01-13. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2005-11-10
Decision date: 2006-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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