DKD · Bacillus Subtilis, Microbiological Assay, Gentamicin
Clinical Toxicology · 21 CFR 862.3450 · Class 2
Overview
| Product Code | DKD |
|---|---|
| Device Name | Bacillus Subtilis, Microbiological Assay, Gentamicin |
| Regulation | 21 CFR 862.3450 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780951 | BIO-MONITOR GENTAMICIN | Monitor Science Corp. | Aug 14, 1978 | SESE |
| K760942 | GENTASAK | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 7, 1977 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Monitor Science Corp. — 1 clearance
