FDA product code DFL: Igm, Ferritin, Antigen, Antiserum, Control
DFL is the FDA product code for igm, ferritin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under DFL, from 3 different applicants. The average 510(k) review took 52 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Igm, Ferritin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DFL clearance
Top DFL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technicon Instruments Corp. | 1 | 1988-09-22 |
| Cyberfluor, Inc. | 1 | 1988-08-04 |
| Gelman Instrument Co. | 1 | 1978-02-03 |
Most recent DFL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883493 | Technicon Instruments Corp. | TECHNICON DPA-1 IMMUNOGLOBULIN M | 1988-09-22 | 37 |
| K882822 | Cyberfluor, Inc. | FIAGEN FERRITIN | 1988-08-04 | 27 |
| K772079 | Gelman Instrument Co. | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M | 1978-02-03 | 92 |
Recalls for DFL devices
openFDA lists no recalls for product code DFL.
Frequently asked questions
What is FDA product code DFL?
DFL is the FDA product code for igm, ferritin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel.
What device class is DFL?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFL?
Across 3 cleared submissions the average was 52 days from receipt to decision (median 37).
Which companies have the most DFL clearances?
Technicon Instruments Corp. (1); Cyberfluor, Inc. (1); Gelman Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DFL
- Run a recall and safety report across every DFL manufacturer
- Watch product code DFL 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.
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