FDA product code DAO: Igm (Mu Chain Specific), Antigen, Antiserum, Control
DAO is the FDA product code for igm (mu chain specific), antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. FDA has cleared 8 510(k) submissions under DAO, from 8 different applicants. The average 510(k) review took 39 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Igm (Mu Chain Specific), 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 DAO clearance
Top DAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics Corp. | 1 | 2004-03-10 |
| Helena Laboratories | 1 | 1998-11-04 |
| Boehringer Mannheim Corp. | 1 | 1996-02-09 |
| Applications Lab | 1 | 1985-03-14 |
| Advanced Cardiovascular Systems, Inc. | 1 | 1984-06-11 |
3 more applicants have DAO clearances. See the full list in Caduvo.
Most recent DAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040431 | Roche Diagnostics Corp. | ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 | 2004-03-10 | 20 |
| K982639 | Helena Laboratories | SPIFE URINE IFE | 1998-11-04 | 98 |
| K955908 | Boehringer Mannheim Corp. | BOEHRINGER MANNHEIM IGM ASSAY | 1996-02-09 | 42 |
| K850586 | Applications Lab | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | 1985-03-14 | 29 |
| K841992 | Advanced Cardiovascular Systems, Inc. | MODIFICATION TO ACS CORONARY GUIDING | 1984-06-11 | 47 |
Recalls for DAO devices
openFDA lists no recalls for product code DAO.
Frequently asked questions
What is FDA product code DAO?
DAO is the FDA product code for igm (mu chain specific), 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 DAO?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAO?
Across 8 cleared submissions the average was 39 days from receipt to decision (median 36).
Which companies have the most DAO clearances?
Roche Diagnostics Corp. (1); Helena Laboratories (1); Boehringer Mannheim Corp. (1); Applications Lab (1); Advanced Cardiovascular Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAO
- Run a recall and safety report across every DAO manufacturer
- Watch product code DAO 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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