Carbamazepine Gen 4— 510(k) K151578

Substantially Equivalent

Roche Diagnostics Operations (Rdo)

FDA 510(k) clearance K151578 for Carbamazepine Gen 4, Substantially Equivalent on 2015-10-22. Applicant: Roche Diagnostics Operations (Rdo).

Clearance details

Applicant: Roche Diagnostics Operations (Rdo)
Product code: Code KLT
Advisory panel: Clinical Toxicology
Date received: 2015-06-11
Decision date: 2015-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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