FDA product code PHK: Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
PHK is the FDA product code for test, cell mediated immune response, liver and small bowel transplant/transplantation. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under PHK reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.
Classification
| Field | Value |
|---|---|
| Device name | Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for PHK devices
openFDA lists no recalls for product code PHK.
Frequently asked questions
What is FDA product code PHK?
PHK is the FDA product code for test, cell mediated immune response, liver and small bowel transplant/transplantation. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is PHK?
Not classified. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PHK
- Run a recall and safety report across every PHK manufacturer
- Watch product code PHK 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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