FDA product code KJY: Malachite Green
KJY is the FDA product code for malachite green. 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 KJY. The average 510(k) review took 29 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Malachite Green |
| 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 KJY clearance
Top KJY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 1 | 1986-11-13 |
Most recent KJY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864033 | Sigma Diagnostics, Inc. | RAPID ACID FAST STAIN | 1986-11-13 | 29 |
Recalls for KJY devices
openFDA lists no recalls for product code KJY.
Frequently asked questions
What is FDA product code KJY?
KJY is the FDA product code for malachite green. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJY?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJY?
Across 1 cleared submissions the average was 29 days from receipt to decision (median 29).
Which companies have the most KJY clearances?
Sigma Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJY
- Run a recall and safety report across every KJY manufacturer
- Watch product code KJY 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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