ADVIA IMS CARBAMAZEPINE METHOD— 510(k) K042808

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K042808 for ADVIA IMS CARBAMAZEPINE METHOD, Substantially Equivalent on 2005-02-08. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code KLT
Advisory panel: Clinical Toxicology
Date received: 2004-10-12
Decision date: 2005-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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