DLP — Radioimmunoassay, Diphenylhydantoin Class II
FDA product code DLP covers "Radioimmunoassay, Diphenylhydantoin", a Class II medical device regulated under 21 CFR 862.3350. Submissions are reviewed by the Clinical Toxicology panel. At least 5 recent 510(k) clearances have been granted under this product code.
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 |