LYE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cytokeratins
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL (K881259) | Triton Biosciences, Inc. | 1988-10-12 | + Add |
| ANTI-CYTOKERATIN MONOCLONAL ANTIBODY (K864893) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-07-07 | + Add |
Track LYE automatically
Every clearance here is in the API, with alerts when new ones post.