BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM— 510(k) K012337

Name: FDA 510(k) clearance K012337
Creator: U.S. Food and Drug Administration
Published: 2001-12-06

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K012337 for BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM, Substantially Equivalent on 2001-12-06. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2001-07-24
Decision date: 2001-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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