FDA product code DAN: Fibrinopeptide A, Antigen, Antiserum, Control
DAN is the FDA product code for fibrinopeptide a, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5350 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under DAN, from 3 different applicants. The average 510(k) review took 69 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | Fibrinopeptide A, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5350 |
| 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 DAN clearance
Top DAN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Altana, Inc. | 1 | 1988-11-16 |
| American Bioproducts Co. | 1 | 1986-02-04 |
| Mallinckrodt Critical Care | 1 | 1982-07-22 |
Most recent DAN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884496 | Altana, Inc. | RIA/MAT FPA TEST KIT | 1988-11-16 | 22 |
| K854384 | American Bioproducts Co. | ASSERACHROM FPA KIT | 1986-02-04 | 97 |
| K821151 | Mallinckrodt Critical Care | RIA-QUANT FPA TEST KIT | 1982-07-22 | 87 |
Recalls for DAN devices
openFDA lists no recalls for product code DAN.
Frequently asked questions
What is FDA product code DAN?
DAN is the FDA product code for fibrinopeptide a, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5350 and reviewed by the Immunology panel.
What device class is DAN?
Class II, regulation 21 CFR 866.5350. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAN?
Across 3 cleared submissions the average was 69 days from receipt to decision (median 87).
Which companies have the most DAN clearances?
Altana, Inc. (1); American Bioproducts Co. (1); Mallinckrodt Critical Care (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAN
- Run a recall and safety report across every DAN manufacturer
- Watch product code DAN 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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