ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR— 510(k) K021535

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K021535 for ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR, Substantially Equivalent on 2002-06-27. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2002-05-10
Decision date: 2002-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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