K042808

Substantially Equivalent

ADVIA IMS CARBAMAZEPINE METHOD

Applicant: Bayer Healthcare, LLC
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.