BAYER SPECIAL CHEMISTRY CALIBRATORS— 510(k) K033380

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K033380 for BAYER SPECIAL CHEMISTRY CALIBRATORS, Substantially Equivalent on 2003-12-16. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2003-10-22
Decision date: 2003-12-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

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