K033007

Substantially Equivalent

BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM

Applicant: Bayer Diagnostics Corp.
Product code: KXT
Advisory panel: Clinical Toxicology
Date received: 2003-09-26
Decision date: 2003-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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