DEN130005 is an FDA 510(k) submission for the QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS. This device is classified as a Organophosphate Test System (Class II - Special Controls, product code PDY).
Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Not Cleared (DENG) decision on August 8, 2013.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3652. 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..
| 510(k) Number | DEN130005 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 28, 2013 |
| Decision Date | August 08, 2013 |
| Days to Decision | 72 days |
| Submission Type | Post-NSE |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | PDY — Organophosphate Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3652 |
| 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. |