DART PHENOBARBITAL ASSAY SYSTEM
Device Facts
| Record ID | K864612 |
|---|---|
| Device Name | DART PHENOBARBITAL ASSAY SYSTEM |
| Applicant | Coulter Electronics, Inc. |
| Product Code | LFN · Clinical Toxicology |
| Decision Date | Jan 13, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3660 |
| Device Class | Class 2 |
Regulatory Classification
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.
