DLP — Radioimmunoassay, Diphenylhydantoin Class II
FDA Device Classification
Classification Details
- Product Code
- DLP
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K894527 | colony laboratories | FPR PHENYTOIN KIT | September 25, 1989 |
| K811775 | kallestad laboratories | KALLESTAD ANTISERA TO PHENYTOIN | July 10, 1981 |
| K792640 | bio-rad | FLUOROMATIC PHENYTOIN FIA | January 11, 1980 |
| K791896 | ventrex laboratories | CENTRIA PHENYTOIN RIA TEST SET | October 17, 1979 |
| K770779 | amersham | PHENYTOIN RIA KIT | June 17, 1977 |