FDA product code DNO: Hemagglutination Inhibition, Gentamicin
DNO is the FDA product code for hemagglutination inhibition, gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DNO. The average 510(k) review took 127 days (median 127).
Classification
| Field | Value |
|---|---|
| Device name | Hemagglutination Inhibition, Gentamicin |
| Device class | Class II |
| Regulation | 21 CFR 862.3450 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DNO clearance
Top DNO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 1 | 1997-02-11 |
Most recent DNO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964009 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS | 1997-02-11 | 127 |
Recalls for DNO devices
openFDA lists no recalls for product code DNO.
Frequently asked questions
What is FDA product code DNO?
DNO is the FDA product code for hemagglutination inhibition, gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel.
What device class is DNO?
Class II, regulation 21 CFR 862.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DNO?
Across 1 cleared submissions the average was 127 days from receipt to decision (median 127).
Which companies have the most DNO clearances?
Beckman Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DNO
- Run a recall and safety report across every DNO manufacturer
- Watch product code DNO 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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