TOX AMMONIA CALIBRATOR— 510(k) K031683

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K031683 for TOX AMMONIA CALIBRATOR, Substantially Equivalent on 2003-08-06. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2003-05-30
Decision date: 2003-08-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

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