Direct LDL Cholesterol (LDL)— 510(k) K161691

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K161691 for Direct LDL Cholesterol (LDL), Substantially Equivalent on 2017-03-20. Applicant: Randox Laboratories Limited.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 2016-06-20
Decision date: 2017-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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