KJI · Radioimmunoassay, Kanamycin
Clinical Toxicology · 21 CFR 862.3520 · Class 2
Overview
| Product Code | KJI |
|---|---|
| Device Name | Radioimmunoassay, Kanamycin |
| Regulation | 21 CFR 862.3520 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in monitoring levels of kanamycin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832769 | AMES TDA KANAMYCIN TEST-CONTROL SERUM | Miles Laboratories, Inc. | Sep 29, 1983 | SESE |
| K823370 | ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY | Syva Co. | Dec 3, 1982 | SESE |
| K823062 | KENAMYCIN FLUORESCENT IMMUNOASSAY FIA | American Diagnostic Corp. | Nov 10, 1982 | SESE |
| K822808 | TDX KENAMYCIN | Abbott Laboratories | Oct 8, 1982 | SESE |
| K782125 | RIA KIT, KANAMYCIN | Diagnostic Products Corp. | Jan 10, 1979 | SESE |
| K772038 | KANAMYCIN RIA | Monitor Science Corp. | Jan 12, 1978 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- American Diagnostic Corp. — 1 clearance
- Diagnostic Products Corp. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
- Monitor Science Corp. — 1 clearance
