EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
Device Facts
| Record ID | K873426 |
|---|---|
| Device Name | EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | KLP · Clinical Toxicology |
| Decision Date | Oct 29, 1987 |
| 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.
