FDA product code LDO: Enzymatic Radiochemical Assay, Tobramycin
LDO is the FDA product code for enzymatic radiochemical assay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under LDO, from 3 different applicants. The average 510(k) review took 65 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic Radiochemical Assay, Tobramycin |
| Device class | Class II |
| Regulation | 21 CFR 862.3900 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LDO clearance
Top LDO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | 1 | 2005-02-07 |
| Cardiac Resucitator Corp. | 1 | 1984-07-19 |
| Syva Co. | 1 | 1983-08-08 |
Most recent LDO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K043384 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III | 2005-02-07 | 60 |
| K841556 | Cardiac Resucitator Corp. | HEART - AID ALS, 95 | 1984-07-19 | 94 |
| K832055 | Syva Co. | EMIT ASSAY AND TOBRAMYCIN | 1983-08-08 | 42 |
Recalls for LDO devices
openFDA lists no recalls for product code LDO.
Frequently asked questions
What is FDA product code LDO?
LDO is the FDA product code for enzymatic radiochemical assay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel.
What device class is LDO?
Class II, regulation 21 CFR 862.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code LDO?
Across 3 cleared submissions the average was 65 days from receipt to decision (median 60).
Which companies have the most LDO clearances?
Ortho-Clinical Diagnostics, Inc. (1); Cardiac Resucitator Corp. (1); Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LDO
- Run a recall and safety report across every LDO manufacturer
- Watch product code LDO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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