DJE · Thin Layer Chromatography, Salicylate
Clinical Toxicology · 21 CFR 862.3830 · Class 2
Overview
| Product Code | DJE |
|---|---|
| Device Name | Thin Layer Chromatography, Salicylate |
| Regulation | 21 CFR 862.3830 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K802615 | EMIT-STM OPIATE ASSAY | Syva Co. | Oct 31, 1980 | SESE |
Top Applicants
- Syva Co. — 1 clearance
