FDA 510(k) Application Details - K954214

Device Classification Name	More FDA Info for this Device
510(K) Number	K954214
Device Name	CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
Applicant	VYSIS 3100 WOODCREEK DR. DOWNERS GROVE, IL 60515 US Other 510(k) Applications for this Company
Contact	VICKI ANASTASI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/1995
Decision Date	01/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review