LDLC3 LDL-Cholesterol Gen.3— 510(k) K143691

Substantially Equivalent

Roche Diagnostics Operations (Rdo)

FDA 510(k) clearance K143691 for LDLC3 LDL-Cholesterol Gen.3, Substantially Equivalent on 2015-01-28. Applicant: Roche Diagnostics Operations (Rdo).

Clearance details

Applicant: Roche Diagnostics Operations (Rdo)
Product code: Code LBR
Advisory panel: Clinical Chemistry
Date received: 2014-12-24
Decision date: 2015-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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