LCE · Radioimmunoassay, Netilmicin (I-125)
Clinical Toxicology · 21 CFR 862.3450 · Class 2
Overview
| Product Code | LCE |
|---|---|
| Device Name | Radioimmunoassay, Netilmicin (I-125) |
| Regulation | 21 CFR 862.3450 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
Identification
A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833715 | EMIT NETILMICIN ASSAY | Syva Co. | Dec 27, 1983 | SESE |
| K832088 | AMES TDA NETILMICIN TEST & SERUM | Miles Laboratories, Inc. | Oct 28, 1983 | SESE |
| K822941 | NETILMICIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | Oct 26, 1982 | SESE |
| K821698 | TDX NETILMICIN | Abbott Laboratories | Jun 22, 1982 | SESE |
| K821399 | MACRO-VUE CARD TEST, NETILMICIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 28, 1982 | SESE |
| K820324 | EMIT AND NETILMICIN ASSAY | Syva Co. | Feb 23, 1982 | SESE |
Top Applicants
- Syva Co. — 2 clearances
- Abbott Laboratories — 1 clearance
- American Diagnostic Corp. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
