Organophosphate Test System
PDY is the FDA product code for Organophosphate Test System, a class II device type, regulated under 21 CFR 862.3652. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PDY
- Device name
- Organophosphate Test System
- FDA 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.
- Regulation
- 21 CFR 862.3652
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PDY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2013 | 1 |
Applicants with the most clearances
Product code PDY| Applicant | Clearances |
|---|---|
| Centers for Disease Control and Prevention | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PDY.
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