FDA product code LDN: Enzymatic Radiochemical Assay, Amikacin
LDN is the FDA product code for enzymatic radiochemical assay, amikacin. It is a Class II device, regulated under 21 CFR 862.3035 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under LDN, from 2 different applicants. The average 510(k) review took 43 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic Radiochemical Assay, Amikacin |
| Device class | Class II |
| Regulation | 21 CFR 862.3035 |
| 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 LDN clearance
Top LDN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 2 | 1983-12-08 |
| Beckman Instruments, Inc. | 1 | 1984-04-02 |
Most recent LDN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840647 | Beckman Instruments, Inc. | AMIKACIN REAGENT TEST KIT | 1984-04-02 | 47 |
| K833546 | Syva Co. | MODIFICATION OF EMIT AND AMIKACIN ASSAY | 1983-12-08 | 55 |
| K820440 | Syva Co. | EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO | 1982-03-15 | 26 |
Recalls for LDN devices
openFDA lists no recalls for product code LDN.
Frequently asked questions
What is FDA product code LDN?
LDN is the FDA product code for enzymatic radiochemical assay, amikacin. It is a Class II device, regulated under 21 CFR 862.3035 and reviewed by the Clinical Toxicology panel.
What device class is LDN?
Class II, regulation 21 CFR 862.3035. Typical premarket route: 510(k).
How long does a 510(k) take for product code LDN?
Across 3 cleared submissions the average was 43 days from receipt to decision (median 47).
Which companies have the most LDN clearances?
Syva Co. (2); Beckman Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LDN
- Run a recall and safety report across every LDN manufacturer
- Watch product code LDN 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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