FDA product code KJX: Jenner Stain
KJX is the FDA product code for jenner stain. 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 KJX. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Jenner Stain |
| 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 KJX clearance
Top KJX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-09-11 |
Most recent KJX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842928 | E K Ind., Inc. | JENNER BLOOD STAIN | 1984-09-11 | 48 |
Recalls for KJX devices
openFDA lists no recalls for product code KJX.
Frequently asked questions
What is FDA product code KJX?
KJX is the FDA product code for jenner stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJX?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJX?
Across 1 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most KJX clearances?
E K Ind., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJX
- Run a recall and safety report across every KJX manufacturer
- Watch product code KJX 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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