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

Name: FDA 510(k) clearance K013272
Creator: U.S. Food and Drug Administration
Published: 2001-10-25

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.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 2001-10-01
Decision date: 2001-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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