FDA 510(k) Application Details - K131508

Device Classification Name	More FDA Info for this Device
510(K) Number	K131508
Device Name	VYSIS D7S486/CEP 7 FISH PROBE KIT
Applicant	ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 US Other 510(k) Applications for this Company
Contact	NANCY W BENGTSON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2013
Decision Date	09/13/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review