PDY — Organophosphate Test System Class II
Classification Details
- Product Code
- PDY
- Device Class
- Class II
- Regulation Number
- 862.3652
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN130005 | centers for disease control and prevention | QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS | August 8, 2013 |