HDL-Cholesterol Gen.4— 510(k) K162593

Substantially Equivalent

Roche Diagnostics Operations (Rdo)

FDA 510(k) clearance K162593 for HDL-Cholesterol Gen.4, Substantially Equivalent on 2016-10-19. Applicant: Roche Diagnostics Operations (Rdo).

Clearance details

Applicant: Roche Diagnostics Operations (Rdo)
Product code: Code LBS
Advisory panel: Clinical Chemistry
Date received: 2016-09-16
Decision date: 2016-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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