THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)— 510(k) K983715

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K983715 for THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1999-05-14. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: 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

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