LDN · Enzymatic Radiochemical Assay, Amikacin
Clinical Toxicology · 21 CFR 862.3035 · Class 2
Overview
| Product Code | LDN |
|---|---|
| Device Name | Enzymatic Radiochemical Assay, Amikacin |
| Regulation | 21 CFR 862.3035 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K840647 | AMIKACIN REAGENT TEST KIT | Beckman Instruments, Inc. | Apr 2, 1984 | SESE |
| K833546 | MODIFICATION OF EMIT AND AMIKACIN ASSAY | Syva Co. | Dec 8, 1983 | SESE |
| K820440 | EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO | Syva Co. | Mar 15, 1982 | SESE |
Top Applicants
- Syva Co. — 2 clearances
- Beckman Instruments, Inc. — 1 clearance
