FDA product code LCE: Radioimmunoassay, Netilmicin (I-125)
LCE is the FDA product code for radioimmunoassay, netilmicin (i-125). It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel. FDA has cleared 6 510(k) submissions under LCE, from 5 different applicants. The average 510(k) review took 43 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Netilmicin (I-125) |
| Device class | Class II |
| Regulation | 21 CFR 862.3450 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LCE clearance
Top LCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 2 | 1983-12-27 |
| Miles Laboratories, Inc. | 1 | 1983-10-28 |
| American Diagnostic Corp. | 1 | 1982-10-26 |
| Abbott Laboratories | 1 | 1982-06-22 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1982-05-28 |
Most recent LCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833715 | Syva Co. | EMIT NETILMICIN ASSAY | 1983-12-27 | 67 |
| K832088 | Miles Laboratories, Inc. | AMES TDA NETILMICIN TEST & SERUM | 1983-10-28 | 122 |
| K822941 | American Diagnostic Corp. | NETILMICIN FLUORESCENT IMMUNOASSAY | 1982-10-26 | 22 |
| K821698 | Abbott Laboratories | TDX NETILMICIN | 1982-06-22 | 14 |
| K821399 | Bd Becton Dickinson Vacutainer Systems Preanalytic | MACRO-VUE CARD TEST, NETILMICIN | 1982-05-28 | 17 |
Recalls for LCE devices
openFDA lists no recalls for product code LCE.
Frequently asked questions
What is FDA product code LCE?
LCE is the FDA product code for radioimmunoassay, netilmicin (i-125). It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel.
What device class is LCE?
Class II, regulation 21 CFR 862.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCE?
Across 6 cleared submissions the average was 43 days from receipt to decision (median 20).
Which companies have the most LCE clearances?
Syva Co. (2); Miles Laboratories, Inc. (1); American Diagnostic Corp. (1); Abbott Laboratories (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCE
- Run a recall and safety report across every LCE manufacturer
- Watch product code LCE 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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