FDA product code DKD: Bacillus Subtilis, Microbiological Assay, Gentamicin
DKD is the FDA product code for bacillus subtilis, microbiological assay, gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DKD, from 2 different applicants. The average 510(k) review took 96 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Bacillus Subtilis, Microbiological Assay, 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 DKD clearance
Top DKD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Monitor Science Corp. | 1 | 1978-08-14 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1977-03-07 |
Most recent DKD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780951 | Monitor Science Corp. | BIO-MONITOR GENTAMICIN | 1978-08-14 | 66 |
| K760942 | Bd Becton Dickinson Vacutainer Systems Preanalytic | GENTASAK | 1977-03-07 | 126 |
Recalls for DKD devices
openFDA lists no recalls for product code DKD.
Frequently asked questions
What is FDA product code DKD?
DKD is the FDA product code for bacillus subtilis, microbiological assay, gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel.
What device class is DKD?
Class II, regulation 21 CFR 862.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKD?
Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).
Which companies have the most DKD clearances?
Monitor Science Corp. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DKD
- Run a recall and safety report across every DKD manufacturer
- Watch product code DKD 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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