BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY— 510(k) K003291

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K003291 for BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY, Substantially Equivalent on 2000-12-05. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code JZO
Advisory panel: Immunology
Date received: 2000-10-20
Decision date: 2000-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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