BAYER IMMUNO 1 HER-2/NEU ASSAY— 510(k) K992228

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K992228 for BAYER IMMUNO 1 HER-2/NEU ASSAY, Substantially Equivalent on 2000-09-29. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code NCW
Advisory panel: Immunology
Date received: 1999-07-02
Decision date: 2000-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.