FDA product code LEF: Stains, Dye Powder
LEF is the FDA product code for stains, dye powder. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under LEF. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Stains, Dye Powder |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LEF clearance
Top LEF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1987-05-21 |
Most recent LEF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871476 | Sigma Chemical Co. | SILVER STAIN REAGENT SYSTEM | 1987-05-21 | 37 |
Recalls for LEF devices
openFDA lists no recalls for product code LEF.
Frequently asked questions
What is FDA product code LEF?
LEF is the FDA product code for stains, dye powder. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is LEF?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LEF?
Across 1 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most LEF clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LEF
- Run a recall and safety report across every LEF manufacturer
- Watch product code LEF 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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