Cleared Traditional

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

K024017 · Bayer Corp. · Immunology

Jan 2003

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K024017 is an FDA 510(k) clearance for the BAYER ADVIA CENTAUR HER-2/NEU ASSAY, a System, Test, Her-2/neu, Monitoring (Class II — Special Controls, product code NCW), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 30, 2003, 57 days after receiving the submission on December 4, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K024017 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2002
Decision Date	January 30, 2003
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF