ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY— 510(k) K020806

Name: FDA 510(k) clearance K020806
Creator: U.S. Food and Drug Administration
Published: 2002-03-27

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K020806 for ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY, Substantially Equivalent on 2002-03-27. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code LOJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2002-03-12
Decision date: 2002-03-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

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