Panels › Clinical Toxicology › Product code LDO · Class 2
Enzymatic Radiochemical Assay, Tobramycin
Regulation 862.3900
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LDO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardiac Resucitator Corp. | 1 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 1 | 0 |
| Syva Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 2005 | K043384 | VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. | LDO |
| Jul 19, 1984 | K841556 | HEART - AID ALS, 95 Cardiac Resucitator Corp. | LDO |
| Aug 8, 1983 | K832055 | EMIT ASSAY AND TOBRAMYCIN Syva Co. | LDO |
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