K-number	K092333
Device name	PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
Applicant	Bioimagene, Inc.
Product code	NQN
Device class	Class II
Decision date	Oct 27, 2010
Decision	Substantially Equivalent
Regulation	864.1860

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View the full FDA submission: accessdata.fda.gov

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PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67

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