LDO
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Enzymatic Radiochemical Assay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043384) | Ortho-Clinical Diagnostics, Inc. | 2005-02-07 |
| HEART - AID ALS, 95 (K841556) | Cardiac Resucitator Corp. | 1984-07-19 |
| EMIT ASSAY AND TOBRAMYCIN (K832055) | Syva Co. | 1983-08-08 |
Track LDO automatically
Every clearance here is in the API, with alerts when new ones post.