ADVIA CENTAUR HOMOCYSTEINE ASSAY— 510(k) K013406

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K013406 for ADVIA CENTAUR HOMOCYSTEINE ASSAY, Substantially Equivalent on 2001-12-18. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code LPS
Advisory panel: Clinical Chemistry
Date received: 2001-10-15
Decision date: 2001-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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