FDA 510(k) Application Details - DEN130005

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130005
Device Name	QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION 4770 BUFORD HWY N.E. ATLANTA, GA 30341 US Other 510(k) Applications for this Company
Contact	ELIZABETH HAMELIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2013
Decision Date	08/08/2013
Decision	DENG -
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review