FDA product code PKM: Chemiluminescent Immunoassay System
PKM is the FDA product code for chemiluminescent immunoassay system. It is a Not classified device, reviewed by the Clinical Toxicology panel. Devices under PKM reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum.
Classification
| Field | Value |
|---|---|
| Device name | Chemiluminescent Immunoassay System |
| Device class | Not classified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PKM devices
openFDA lists no recalls for product code PKM.
Frequently asked questions
What is FDA product code PKM?
PKM is the FDA product code for chemiluminescent immunoassay system. It is a Not classified device, reviewed by the Clinical Toxicology panel.
What device class is PKM?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PKM
- Run a recall and safety report across every PKM manufacturer
- Watch product code PKM 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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