K030804

Substantially Equivalent

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

Applicant: Bayer Healthcare, LLC
Product code: JIX
Advisory panel: Clinical Chemistry
Date received: 2003-03-13
Decision date: 2003-04-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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