ADVIA CHEMISTRY TOTAL BILIRUBIN_2— 510(k) K063845

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K063845 for ADVIA CHEMISTRY TOTAL BILIRUBIN_2, Substantially Equivalent on 2007-12-07. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant
Bayer Healthcare, LLC
Product code
Code JFM
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tarrytown, NY, US
Download summary PDFView on FDA.gov ↗

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