DLP · Radioimmunoassay, Diphenylhydantoin
Clinical Toxicology · 21 CFR 862.3350 · Class 2
Overview
| Product Code | DLP |
|---|---|
| Device Name | Radioimmunoassay, Diphenylhydantoin |
| Regulation | 21 CFR 862.3350 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K894527 | FPR PHENYTOIN KIT | Colony Laboratories, Inc. | Sep 25, 1989 | SESE |
| K811775 | KALLESTAD ANTISERA TO PHENYTOIN | Kallestad Laboratories, Inc. | Jul 10, 1981 | SESE |
| K792640 | FLUOROMATIC PHENYTOIN FIA | Bio-Rad | Jan 11, 1980 | SESE |
| K791896 | CENTRIA PHENYTOIN RIA TEST SET | Ventrex Laboratories, Inc. | Oct 17, 1979 | SESE |
| K770779 | PHENYTOIN RIA KIT | Amersham Corp. | Jun 17, 1977 | SESE |
Top Applicants
- Amersham Corp. — 1 clearance
- Bio-Rad — 1 clearance
- Colony Laboratories, Inc. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
- Ventrex Laboratories, Inc. — 1 clearance
