CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM— 510(k) K013568

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K013568 for CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, Substantially Equivalent on 2001-12-21. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code DHX
Advisory panel: Immunology
Date received: 2001-10-26
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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