FDA 510(k) Application Details - K100015

Device Classification Name	More FDA Info for this Device
510(K) Number	K100015
Device Name	VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
Applicant	ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 US Other 510(k) Applications for this Company
Contact	PAMELA L SWATKOWSKI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2010
Decision Date	08/09/2011
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