FDA product code KFD: Aniline Blue
KFD is the FDA product code for aniline blue. 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 KFD. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Aniline Blue |
| 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 KFD clearance
Top KFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Devetec, Inc. | 1 | 1989-07-25 |
Most recent KFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894045 | Devetec, Inc. | MODIFIED POLYCHROME IV STAIN | 1989-07-25 | 48 |
Recalls for KFD devices
openFDA lists no recalls for product code KFD.
Frequently asked questions
What is FDA product code KFD?
KFD is the FDA product code for aniline blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KFD?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KFD?
Across 1 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most KFD clearances?
Devetec, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KFD
- Run a recall and safety report across every KFD manufacturer
- Watch product code KFD 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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