FDA product code KKK: Sudan Iv
KKK is the FDA product code for sudan iv. 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 KKK. The average 510(k) review took 48 days (median 48). FDA has posted 2 recalls for KKK devices.
Classification
| Field | Value |
|---|---|
| Device name | Sudan Iv |
| 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 KKK clearance
Top KKK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-09-11 |
Most recent KKK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842916 | E K Ind., Inc. | SUDAN IV HERXHEIMER | 1984-09-11 | 48 |
Recalls for KKK devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-07-28.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code KKK?
KKK is the FDA product code for sudan iv. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KKK?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KKK?
Across 1 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most KKK clearances?
E K Ind., Inc. (1).
Have KKK devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-07-28.
Next steps
- Run an FDA pathway report with predicate devices for product code KKK
- Run a recall and safety report across every KKK manufacturer
- Watch product code KKK 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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