DFI — Total Spinal-Fluid, Antigen, Antiserum, Control Class I
FDA product code DFI covers "Total Spinal-Fluid, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5860. Submissions are reviewed by the Immunology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DFI
- Device Class
- Class I
- Regulation Number
- 866.5860
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K854190 | canyon diagnostics | CANTROL SPINAL FLUID CONTROL | November 25, 1985 |
| K843122 | isolab | RESOLVE-CSF | November 30, 1984 |
| K840974 | somas medical industries | SOMAS HUMAN SPINAL FLUID CONTROL | April 5, 1984 |
| K832821 | intl. diagnostic technology | FIAX IGG TEST | October 14, 1983 |