Total Spinal-Fluid, Antigen, Antiserum, Control
The Total Spinal-Fluid Antigen, Antiserum, and Control is a diagnostic immunological reagent used to detect and characterize proteins or other analytes in cerebrospinal fluid samples. It is classified as FDA Class 1, the lowest risk category, meaning it is subject only to general controls such as proper labeling and manufacturing standards, with no premarket notification required. This device is regulated under 21 CFR 866.5860 within the Immunology specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- DFI
- Device Class
- FDA class 1
- Regulation Number
- 866.5860
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K854190 | CANTROL SPINAL FLUID CONTROL | Nov 25, 1985 | Substantially Equivalent | Canyon Diagnostics, Inc. |
| K843122 | RESOLVE-CSF | Nov 30, 1984 | Substantially Equivalent | Isolab, Inc. |
| K840974 | SOMAS HUMAN SPINAL FLUID CONTROL | Apr 05, 1984 | Substantially Equivalent | Somas Medical Industries, Inc. |
| K832821 | FIAX IGG TEST | Oct 14, 1983 | Substantially Equivalent | Intl. Diagnostic Technology |
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.