Total Bilirubin— 510(k) K152344

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K152344 for Total Bilirubin, Substantially Equivalent on 2016-01-28. Applicant: Randox Laboratories Limited.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code JFM
Advisory panel: Clinical Chemistry
Date received: 2015-08-19
Decision date: 2016-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, County Antrim, GB

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