FDA 510(k) Application Details - DEN170019

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170019
Device Name	Vitamin D 200M Assay for the Topaz System
Applicant	AB SCIEX LLC 500 Old Connecticut Path Framingham, MA 01701 US Other 510(k) Applications for this Company
Contact	Shilpa Sharma Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2017
Decision Date	05/18/2017
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review