Direct Bilirubin— 510(k) K152343

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K152343 for Direct Bilirubin, Substantially Equivalent on 2016-02-16. 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: 2016-02-16
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.