Skip to contentDe Novo DEN130005
- Device
- QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
- Contact
- elizabeth hamelin
- De Novo number
- DEN130005
- Product code
- PDY
- Regulation
- 862.3652
- Classification name
- organophosphate test system
- Decision
- granted (DENG)
- Decision date
- 2013-08-08
- Date received
- 2013-05-28
- Classification advisory
- Toxicology
- Review advisory
- Toxicology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PDY
- Device name
- Organophosphate Test System
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation
- 862.3652
- Implant
- N
- Life sustain/support
- N