FDA product code PCZ: Investigational Use Only - Immunology
PCZ is the FDA product code for investigational use only - immunology. It is a Not classified device, reviewed by the Hematology panel. Devices under PCZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Investigational use only and for products imported into the US only.
Classification
| Field | Value |
|---|---|
| Device name | Investigational Use Only - Immunology |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for PCZ devices
openFDA lists no recalls for product code PCZ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q4240 — Corecyte, for topical use only, per 0.5 cc
- Q4241 — Polycyte, for topical use only, per 0.5 cc
Frequently asked questions
What is FDA product code PCZ?
PCZ is the FDA product code for investigational use only - immunology. It is a Not classified device, reviewed by the Hematology panel.
What device class is PCZ?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PCZ
- Run a recall and safety report across every PCZ manufacturer
- Watch product code PCZ 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.