FDA product code LEE: Stains, Dye Solution
LEE is the FDA product code for stains, dye solution. 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 LEE. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Stains, Dye Solution |
| 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 LEE clearance
Top LEE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| V-Tech, Inc. | 1 | 1982-12-15 |
Most recent LEE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823363 | V-Tech, Inc. | COUNT-10 STAIN | 1982-12-15 | 36 |
Recalls for LEE devices
openFDA lists no recalls for product code LEE.
Frequently asked questions
What is FDA product code LEE?
LEE is the FDA product code for stains, dye solution. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is LEE?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LEE?
Across 1 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most LEE clearances?
V-Tech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LEE
- Run a recall and safety report across every LEE manufacturer
- Watch product code LEE 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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