ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY— 510(k) K013272

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K013272 for ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY, Substantially Equivalent on 2001-10-25. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code KLS
Advisory panel: Clinical Toxicology
Date received: 2001-10-01
Decision date: 2001-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Tarrytown, NY, US

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