EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
Device Facts
| Record ID | K010814 |
|---|---|
| Device Name | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 |
| Applicant | Syva Co., Dade Behring, Inc. |
| Product Code | KLT · Clinical Toxicology |
| Decision Date | Apr 13, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 862.3645 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.
