BAYER ADVIA CENTAUR HER-2/NEU ASSAY— 510(k) K024017

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K024017 for BAYER ADVIA CENTAUR HER-2/NEU ASSAY, Substantially Equivalent on 2003-01-30. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code NCW
Advisory panel: Immunology
Date received: 2002-12-04
Decision date: 2003-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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