THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)— 510(k) K964703

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K964703 for THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1997-12-01. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code MOI
Advisory panel: Immunology
Date received: 1996-11-22
Decision date: 1997-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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