FDA product code MYY: Separator, Semi-Automated, Blood Component
MYY is the FDA product code for separator, semi-automated, blood component. It is a Class I device, reviewed by the Hematology panel. Devices under MYY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Separator, Semi-Automated, Blood Component |
| Device class | Class I |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for MYY devices
openFDA lists no recalls for product code MYY.
Frequently asked questions
What is FDA product code MYY?
MYY is the FDA product code for separator, semi-automated, blood component. It is a Class I device, reviewed by the Hematology panel.
What device class is MYY?
Class I. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MYY
- Run a recall and safety report across every MYY manufacturer
- Watch product code MYY 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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