Cytokeratins
Cytokeratins (product code LYE) are immunological reagents used in histopathology and immunohistochemistry to detect cytokeratin proteins in tissue specimens, aiding in the identification and classification of epithelial tumors and metastatic carcinomas. Regulated under 21 CFR 866.5550 and classified as a Class 2 device, they require a 510(k) premarket notification and are eligible for third-party review. The device falls under the Immunology specialty with review by the Pathology (PA) panel. They are not implants and are not life-sustaining.
Basic Information
- Product Code
- LYE
- Device Class
- FDA class 2
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881259 | MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL | Oct 12, 1988 | Substantially Equivalent | Triton Biosciences, Inc. |
| K864893 | ANTI-CYTOKERATIN MONOCLONAL ANTIBODY | Jul 07, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.