FDA product code JKY: Oxalydihydrazide (Spectroscopic), Copper
JKY is the FDA product code for oxalydihydrazide (spectroscopic), copper. It is a Class I device, regulated under 21 CFR 862.1190 and reviewed by the Clinical Chemistry panel. Devices under JKY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Oxalydihydrazide (Spectroscopic), Copper |
| Device class | Class I |
| Regulation | 21 CFR 862.1190 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JKY devices
openFDA lists no recalls for product code JKY.
Frequently asked questions
What is FDA product code JKY?
JKY is the FDA product code for oxalydihydrazide (spectroscopic), copper. It is a Class I device, regulated under 21 CFR 862.1190 and reviewed by the Clinical Chemistry panel.
What device class is JKY?
Class I, regulation 21 CFR 862.1190. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JKY
- Run a recall and safety report across every JKY manufacturer
- Watch product code JKY 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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