FDA product code PHY: Sparse Sample Pk Profile And Dosing Software
PHY is the FDA product code for sparse sample pk profile and dosing software. It is a Class II device, regulated under 21 CFR 868.1890 and reviewed by the Hematology panel. Devices under PHY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
To estimate PK profile and dosing calculation.
Classification
| Field | Value |
|---|---|
| Device name | Sparse Sample Pk Profile And Dosing Software |
| Device class | Class II |
| Regulation | 21 CFR 868.1890 |
| Review panel | HE — Hematology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Recalls for PHY devices
openFDA lists no recalls for product code PHY.
Frequently asked questions
What is FDA product code PHY?
PHY is the FDA product code for sparse sample pk profile and dosing software. It is a Class II device, regulated under 21 CFR 868.1890 and reviewed by the Hematology panel.
What device class is PHY?
Class II, regulation 21 CFR 868.1890. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PHY
- Run a recall and safety report across every PHY manufacturer
- Watch product code PHY 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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