MSL · System, Test, Topiramatee
Clinical Toxicology · 21 CFR 862.3350 · Class 2
Overview
| Product Code | MSL |
|---|---|
| Device Name | System, Test, Topiramatee |
| Regulation | 21 CFR 862.3350 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970510 | INNOFLOUR TOPIRAMATE REAGENT SET | Oxis Intl., Inc. | May 12, 1997 | SESE |
Top Applicants
- Oxis Intl., Inc. — 1 clearance
