MODIFICATION OF EMIT AND AMIKACIN ASSAY
Device Facts
| Record ID | K833546 |
|---|---|
| Device Name | MODIFICATION OF EMIT AND AMIKACIN ASSAY |
| Applicant | Syva Co. |
| Product Code | LDN · Clinical Toxicology |
| Decision Date | Dec 8, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3035 |
| Device Class | Class 2 |
Regulatory Classification
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.
