FDA product code LPI: Kit, Assay, Progesterone Receptor
LPI is the FDA product code for kit, assay, progesterone receptor. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Clinical Chemistry panel. Devices under LPI reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Assay, Progesterone Receptor |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for LPI devices
openFDA lists no recalls for product code LPI.
Frequently asked questions
What is FDA product code LPI?
LPI is the FDA product code for kit, assay, progesterone receptor. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Clinical Chemistry panel.
What device class is LPI?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LPI
- Run a recall and safety report across every LPI manufacturer
- Watch product code LPI 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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