FDA 510(k) Application Details - DEN130010

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130010
Device Name	VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
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	PDO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2013
Decision Date	07/29/2013
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review