FDA product code DFI: Total Spinal-Fluid, Antigen, Antiserum, Control
DFI is the FDA product code for total spinal-fluid, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5860 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under DFI, from 4 different applicants. The average 510(k) review took 60 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Total Spinal-Fluid, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5860 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DFI clearance
Top DFI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Canyon Diagnostics, Inc. | 1 | 1985-11-25 |
| Isolab, Inc. | 1 | 1984-11-30 |
| Somas Medical Industries, Inc. | 1 | 1984-04-05 |
| Intl. Diagnostic Technology | 1 | 1983-10-14 |
Most recent DFI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854190 | Canyon Diagnostics, Inc. | CANTROL SPINAL FLUID CONTROL | 1985-11-25 | 41 |
| K843122 | Isolab, Inc. | RESOLVE-CSF | 1984-11-30 | 114 |
| K840974 | Somas Medical Industries, Inc. | SOMAS HUMAN SPINAL FLUID CONTROL | 1984-04-05 | 30 |
| K832821 | Intl. Diagnostic Technology | FIAX IGG TEST | 1983-10-14 | 56 |
Recalls for DFI devices
openFDA lists no recalls for product code DFI.
Frequently asked questions
What is FDA product code DFI?
DFI is the FDA product code for total spinal-fluid, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5860 and reviewed by the Immunology panel.
What device class is DFI?
Class I, regulation 21 CFR 866.5860. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DFI?
Across 4 cleared submissions the average was 60 days from receipt to decision (median 48).
Which companies have the most DFI clearances?
Canyon Diagnostics, Inc. (1); Isolab, Inc. (1); Somas Medical Industries, Inc. (1); Intl. Diagnostic Technology (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DFI
- Run a recall and safety report across every DFI manufacturer
- Watch product code DFI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times