FDA product code MYK: Kit, Cord Blood Collection
MYK is the FDA product code for kit, cord blood collection. It is a Not classified device, reviewed by the Hematology panel. Devices under MYK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Cord Blood Collection |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for MYK devices
openFDA lists no recalls for product code MYK.
Frequently asked questions
What is FDA product code MYK?
MYK is the FDA product code for kit, cord blood collection. It is a Not classified device, reviewed by the Hematology panel.
What device class is MYK?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MYK
- Run a recall and safety report across every MYK manufacturer
- Watch product code MYK 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.