FDA 510(k) Application Details - K091960

Device Classification Name	More FDA Info for this Device
510(K) Number	K091960
Device Name	VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
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	OWK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2009
Decision Date	08/29/2011
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