Device Classification Name |
organophosphate test system
|
De Novo Number |
DEN130005 |
510(K) Number |
K122282
|
Device Name |
QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS |
Requester |
centers for disease control and prevention |
4770 buford hwy n.e. |
atlanta,
GA
30341
|
|
Contact |
elizabeth hamelin |
|
Regulation Number | 862.3652
|
Classification Product Code |
|
Date Received | 05/28/2013 |
Decision Date | 08/08/2013 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Toxicology
|
Review Advisory Committee |
Toxicology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|