Product code DPE
- Device name
- Thin Layer Chromatography, Diphenylhydantoin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3350
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K791979 | TECHNICON FAST-LC SYS. ANTICONVU DRUGS | Technicon Instruments Corp. | 1979-11-13 |