FDA product code KFE: Neutral Red
KFE is the FDA product code for neutral red. 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 KFE. The average 510(k) review took 15 days (median 15).
Classification
| Field | Value |
|---|---|
| Device name | Neutral Red |
| 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 KFE clearance
Top KFE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1987-04-29 |
Most recent KFE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871477 | Sigma Chemical Co. | NEUTRAL RED | 1987-04-29 | 15 |
Recalls for KFE devices
openFDA lists no recalls for product code KFE.
Frequently asked questions
What is FDA product code KFE?
KFE is the FDA product code for neutral red. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KFE?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KFE?
Across 1 cleared submissions the average was 15 days from receipt to decision (median 15).
Which companies have the most KFE clearances?
Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KFE
- Run a recall and safety report across every KFE manufacturer
- Watch product code KFE 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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