LFN · Nephelometric Inhibition Immunoassay, Phenobarbital
Clinical Toxicology · 21 CFR 862.3660 · Class 2
Overview
| Product Code | LFN |
|---|---|
| Device Name | Nephelometric Inhibition Immunoassay, 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934388 | QMS PHENOBARBITAL | Seradyn, Inc. | Feb 25, 1994 | SESE |
| K864612 | DART PHENOBARBITAL ASSAY SYSTEM | Coulter Electronics, Inc. | Jan 13, 1987 | SESE |
| K860304 | DUPONT PHENOBARBITAL ASSAY | E.I. Dupont DE Nemours & Co., Inc. | Feb 28, 1986 | SESE |
| K860303 | DUPONT PHENOBARBITAL CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | Feb 28, 1986 | SESE |
| K821543 | IPA FOR DETECTION OF PHENOBARBITAL | Electro-Nucleonics Laboratories, Inc. | Jun 3, 1982 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 2 clearances
- Coulter Electronics, Inc. — 1 clearance
- Electro-Nucleonics Laboratories, Inc. — 1 clearance
- Seradyn, Inc. — 1 clearance
