ONLINE TDM Vancomycin Gen.3— 510(k) K152245

Substantially Equivalent

Roche Diagnostics Operations (Rdo)

FDA 510(k) clearance K152245 for ONLINE TDM Vancomycin Gen.3, Substantially Equivalent on 2016-01-08. Applicant: Roche Diagnostics Operations (Rdo).

Clearance details

Applicant: Roche Diagnostics Operations (Rdo)
Product code: Code LEH
Advisory panel: Clinical Toxicology
Date received: 2015-08-10
Decision date: 2016-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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