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

Name: FDA 510(k) clearance K080910
Creator: U.S. Food and Drug Administration
Published: 2009-02-04

Substantially Equivalent

Bioimagene, Inc.

FDA 510(k) clearance K080910 for PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS, Substantially Equivalent on 2009-02-04. Applicant: Bioimagene, Inc.. Device class: 2.

Clearance details

Applicant: Bioimagene, Inc.
Product code: Code NOT
Device class: Class 2
Regulation: 21 CFR 864.1860
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 ↗

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