FDA product code LYE: Cytokeratins
LYE is the FDA product code for cytokeratins. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under LYE, from 2 different applicants. The average 510(k) review took 386 days (median 386).
Classification
| Field | Value |
|---|---|
| Device name | Cytokeratins |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LYE clearance
Top LYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Triton Biosciences, Inc. | 1 | 1988-10-12 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1988-07-07 |
Most recent LYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881259 | Triton Biosciences, Inc. | MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL | 1988-10-12 | 203 |
| K864893 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ANTI-CYTOKERATIN MONOCLONAL ANTIBODY | 1988-07-07 | 570 |
Recalls for LYE devices
openFDA lists no recalls for product code LYE.
Frequently asked questions
What is FDA product code LYE?
LYE is the FDA product code for cytokeratins. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Pathology panel.
What device class is LYE?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYE?
Across 2 cleared submissions the average was 386 days from receipt to decision (median 386).
Which companies have the most LYE clearances?
Triton Biosciences, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LYE
- Run a recall and safety report across every LYE manufacturer
- Watch product code LYE 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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