LYE — Cytokeratins Class II
FDA product code LYE covers "Cytokeratins", a Class II medical device regulated under 21 CFR 866.5550. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LYE
- Device Class
- Class II
- Regulation Number
- 866.5550
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No