FDA product code KKJ: Sudan Iii
KKJ is the FDA product code for sudan iii. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KKJ. The average 510(k) review took 31 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Sudan Iii |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KKJ clearance
Top KKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jayco Pharmaceuticals | 1 | 1981-05-01 |
Most recent KKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810875 | Jayco Pharmaceuticals | FECAL STAINING KIT | 1981-05-01 | 31 |
Recalls for KKJ devices
openFDA lists no recalls for product code KKJ.
Frequently asked questions
What is FDA product code KKJ?
KKJ is the FDA product code for sudan iii. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KKJ?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KKJ?
Across 1 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most KKJ clearances?
Jayco Pharmaceuticals (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KKJ
- Run a recall and safety report across every KKJ manufacturer
- Watch product code KKJ 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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