FDA product code KKA: Methyl Orange
KKA is the FDA product code for methyl orange. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under KKA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Methyl Orange |
| 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 KKA devices
openFDA lists no recalls for product code KKA.
Frequently asked questions
What is FDA product code KKA?
KKA is the FDA product code for methyl orange. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KKA?
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 KKA
- Run a recall and safety report across every KKA manufacturer
- Watch product code KKA 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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