EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
Device Facts
| Record ID | K913190 |
|---|---|
| Device Name | EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS |
| Applicant | Syva Co. |
| Product Code | DLZ · Clinical Toxicology |
| Decision Date | Aug 26, 1991 |
| 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.
