CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM— 510(k) K021428

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K021428 for CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM, Substantially Equivalent on 2002-07-05. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code JFY
Advisory panel: Clinical Chemistry
Date received: 2002-05-03
Decision date: 2002-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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