Cleared Traditional

BAYER IMMUNO 1 HER-2/NEU ASSAY

K992228 · Bayer Corp. · Immunology

Sep 2000

Decision

455d

Days

Class 2

Risk

About This 510(k) Submission

K992228 is an FDA 510(k) clearance for the BAYER IMMUNO 1 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 September 29, 2000, 455 days after receiving the submission on July 2, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K992228 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 1999
Decision Date	September 29, 2000
Days to Decision	455 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF