FDA product code PCO: Immunoglobulin G Lambda Heavy And Light Chain Combined
PCO is the FDA product code for immunoglobulin g lambda heavy and light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. Devices under PCO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended for the in-vitro quantification of IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Immunoglobulin G Lambda Heavy And Light Chain Combined |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PCO devices
openFDA lists no recalls for product code PCO.
Frequently asked questions
What is FDA product code PCO?
PCO is the FDA product code for immunoglobulin g lambda heavy and light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is PCO?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PCO
- Run a recall and safety report across every PCO manufacturer
- Watch product code PCO 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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