DKP · Radioimmunoassay, Phenobarbital
Clinical Toxicology · 21 CFR 862.3660 · Class 2
Overview
| Product Code | DKP |
|---|---|
| Device Name | Radioimmunoassay, Phenobarbital |
| Regulation | 21 CFR 862.3660 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K844167 | ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 27, 1984 | SESE |
| K800090 | FLUOROMATIC PHENOLBARBITAL FIA | Bio-Rad | Jan 23, 1980 | SESE |
| K772111 | IN VITRO PHENOBARBITAL RIA TEST | Clinical Assays, Inc. | Nov 28, 1977 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bio-Rad — 1 clearance
- Clinical Assays, Inc. — 1 clearance
