DID · Bacillus Subtilis Microbiology Assay, Tobramycin
Clinical Toxicology · 21 CFR 862.3900 · Class 2
Overview
| Product Code | DID |
|---|---|
| Device Name | Bacillus Subtilis Microbiology Assay, Tobramycin |
| Regulation | 21 CFR 862.3900 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K820773 | EMIT-ST URINE COCAINE METABOLITE ASSAY | Syva Co. | Apr 8, 1982 | SESE |
| K802038 | PHENYTOIN REAGENT TEST KIT | Beckman Instruments, Inc. | Oct 23, 1980 | SESE |
| K780950 | BIO-MONITOR TOBRAMYCIN | Monitor Science Corp. | Aug 14, 1978 | SESE |
| K780182 | TOBRAMYCIN 125I RIA KIT | New England Nuclear | Feb 13, 1978 | SESE |
| K780048 | AMINOGLYCOSIDE TEST SYSTEM | Nichols Institute Diagnostics | Jan 20, 1978 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 1 clearance
- Monitor Science Corp. — 1 clearance
- New England Nuclear — 1 clearance
- Nichols Institute Diagnostics — 1 clearance
- Syva Co. — 1 clearance
