Enzymatic Radiochemical Assay, Tobramycin
FDA product code LDO · Class II (moderate risk) · 21 CFR 862.3900 · Clinical Toxicology
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043384 | Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…LDO · Traditional | Ortho-Clinical Diagnostics, Inc. | 02/07/2005SE |
| K841556 | Heart - Aid Als, 95LDO · Traditional | Cardiac Resucitator Corp. | 07/19/1984SE |
| K832055 | Emit Assay and TobramycinLDO · Traditional | Syva Co. | 08/08/1983SE |