FDA product code NBO: Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
NBO is the FDA product code for autoantibodies, skin (desmoglein 1 and desmoglein 3). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under NBO, from 2 different applicants. The average 510(k) review took 278 days (median 278).
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| 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 NBO clearance
Top NBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euroimmun Us, Inc. | 1 | 2010-09-02 |
| Rhigene, Inc. | 1 | 2000-06-09 |
Most recent NBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091969 | Euroimmun Us, Inc. | EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) | 2010-09-02 | 428 |
| K000336 | Rhigene, Inc. | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E | 2000-06-09 | 127 |
Recalls for NBO devices
openFDA lists no recalls for product code NBO.
Frequently asked questions
What is FDA product code NBO?
NBO is the FDA product code for autoantibodies, skin (desmoglein 1 and desmoglein 3). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is NBO?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBO?
Across 2 cleared submissions the average was 278 days from receipt to decision (median 278).
Which companies have the most NBO clearances?
Euroimmun Us, Inc. (1); Rhigene, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NBO
- Run a recall and safety report across every NBO manufacturer
- Watch product code NBO 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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