SFC — Neurologic Disease Risk Assessment Molecular Test Class II
FDA product code SFC covers "Neurologic Disease Risk Assessment Molecular Test", a Class II medical device regulated under 21 CFR 866.5850. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SFC
- Device Class
- Class II
- Regulation Number
- 866.5850
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240032 | firalis | APO-Easy Genotyping kit | June 12, 2025 |