510(k) K080910— PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS

Substantially Equivalent

Bioimagene, Inc.

Clearance details

Applicant: Bioimagene, Inc.
Product code: Code NOT
Advisory panel: Hematology
Date received: 2008-04-01
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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