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

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..

Clearance details

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

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