K983715

Substantially Equivalent

THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Applicant: Bayer Corp.
Product code: LTK
Advisory panel: Immunology
Date received: 1998-10-21
Decision date: 1999-05-14
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.