FDA product code KJT: Indigocarmine
KJT is the FDA product code for indigocarmine. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under KJT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Indigocarmine |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KJT devices
openFDA lists no recalls for product code KJT.
Frequently asked questions
What is FDA product code KJT?
KJT is the FDA product code for indigocarmine. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJT?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KJT
- Run a recall and safety report across every KJT manufacturer
- Watch product code KJT 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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