BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM— 510(k) K033007

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K033007 for BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM, Substantially Equivalent on 2003-11-14. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: 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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