Cleared Traditional

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS

K080910 · Bioimagene, Inc. · Pathology

Feb 2009

Decision

309d

Days

—

Risk

About This 510(k) Submission

K080910 is an FDA 510(k) clearance for the PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS, submitted by Bioimagene, Inc. (Cupertino, US). The FDA issued a Cleared decision on February 4, 2009, 309 days after receiving the submission on April 1, 2008. This device falls under the Pathology review panel.

Submission Details

510(k) Number	K080910 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2008
Decision Date	February 04, 2009
Days to Decision	309 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF