510(k) DEN130005
- Device
- QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
- Applicant
- Centers for Disease Control and Prevention
- 510(k) number
- DEN130005
- Product code
- PDY
- Decision
- Unknown (DENG)
- Decision date
- 2013-08-08
- Date received
- 2013-05-28
- Regulation
- 862.3652
- Classification name
- Organophosphate Test System
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- ELIZABETH HAMELIN
- Address
- 4770 Buford Hwy. NE Atlanta GA US 30341 30341
Source Documents
510(k) summary PDF not indicated by FDA