FDA product code LED: Stains, Chemical Solution
LED is the FDA product code for stains, chemical solution. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 16 510(k) submissions under LED, from 9 different applicants. The average 510(k) review took 32 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Stains, Chemical 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 |
Top LED applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cytocolor, Inc. | 5 | 1986-02-20 |
| Difco Laboratories, Inc. | 2 | 1986-03-12 |
| E K Ind., Inc. | 2 | 1984-09-11 |
| Sigma Chemical Co. | 2 | 1983-10-31 |
| Scandinavian Formulas, Inc. | 1 | 2005-08-08 |
4 more applicants have LED clearances. See the full list in Caduvo.
Most recent LED clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051409 | Scandinavian Formulas, Inc. | SLIVASURE | 2005-08-08 | 69 |
| K023046 | Sinclair Pharmaceuticals, Ltd. | SST SALIVA SUPPORTING TABLETS | 2002-12-02 | 81 |
| K860795 | Difco Laboratories, Inc. | SPOTTEST CALCOFLUOR WHITE REAGENT | 1986-03-12 | 8 |
| K860321 | Cytocolor, Inc. | LYSOCOLOR | 1986-02-20 | 23 |
| K860320 | Cytocolor, Inc. | GRANULOCOLOR | 1986-02-20 | 23 |
Recalls for LED devices
openFDA lists no recalls for product code LED.
Frequently asked questions
What is FDA product code LED?
LED is the FDA product code for stains, chemical solution. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is LED?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LED?
Across 16 cleared submissions the average was 32 days from receipt to decision (median 23).
Which companies have the most LED clearances?
Cytocolor, Inc. (5); Difco Laboratories, Inc. (2); E K Ind., Inc. (2); Sigma Chemical Co. (2); Scandinavian Formulas, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LED
- Run a recall and safety report across every LED manufacturer
- Watch product code LED 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.