DJQ · Test Reagents For Phenothiazine
Clinical Toxicology · 21 CFR 862.3670 · Class 2
Overview
| Product Code | DJQ |
|---|---|
| Device Name | Test Reagents For Phenothiazine |
| Regulation | 21 CFR 862.3670 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A phenothiazine test system is a device intended to measure any of the drugs of the phenothiazine class in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenothiazine use or overdose.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K894657 | POLYSTAN HEART-LUNG MACHINE SYSTEM | Polystan C/O Vitalcor, Inc. | Mar 28, 1990 | SESE |
Top Applicants
- Polystan C/O Vitalcor, Inc. — 1 clearance
