FDA product code KJN: Brilliant Cresyl Blue
KJN is the FDA product code for brilliant cresyl 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 KJN. The average 510(k) review took 29 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Brilliant Cresyl 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 KJN clearance
Top KJN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R&D Systems, Inc. | 1 | 1982-06-02 |
Most recent KJN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821318 | R&D Systems, Inc. | RETIC SET | 1982-06-02 | 29 |
Recalls for KJN devices
openFDA lists no recalls for product code KJN.
Frequently asked questions
What is FDA product code KJN?
KJN is the FDA product code for brilliant cresyl blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJN?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJN?
Across 1 cleared submissions the average was 29 days from receipt to decision (median 29).
Which companies have the most KJN clearances?
R&D Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJN
- Run a recall and safety report across every KJN manufacturer
- Watch product code KJN 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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