510(k) K013606— ACS 180 HOMOCYSTEINE ASSAY

Substantially Equivalent

Bayer Diagnostics Corp.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code LPS
Advisory panel: Clinical Chemistry
Date received: 2001-10-31
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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