PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67— 510(k) K092333

Name: FDA 510(k) clearance K092333
Creator: U.S. Food and Drug Administration
Published: 2010-10-27

Substantially Equivalent

Bioimagene, Inc.

FDA 510(k) clearance K092333 for PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67, Substantially Equivalent on 2010-10-27. Applicant: Bioimagene, Inc.. Device class: 2.

Clearance details

Applicant: Bioimagene, Inc.
Product code: Code NQN
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2009-08-04
Decision date: 2010-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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