FDA product code LPJ: Kit, Assay, Estrogen Receptor
LPJ is the FDA product code for kit, assay, estrogen receptor. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Clinical Chemistry panel. Devices under LPJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 1 recall for LPJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Assay, Estrogen Receptor |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for LPJ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-27.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code LPJ?
LPJ is the FDA product code for kit, assay, estrogen receptor. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Clinical Chemistry panel.
What device class is LPJ?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Have LPJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code LPJ
- Run a recall and safety report across every LPJ manufacturer
- Watch product code LPJ 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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