FDA product code PDC: Investigational Use Only - Hematology
PDC is the FDA product code for investigational use only - hematology. It is a Not classified device, reviewed by the Hematology panel. Devices under PDC 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 - Hematology |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for PDC devices
openFDA lists no recalls for product code PDC.
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 PDC?
PDC is the FDA product code for investigational use only - hematology. It is a Not classified device, reviewed by the Hematology panel.
What device class is PDC?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PDC
- Run a recall and safety report across every PDC manufacturer
- Watch product code PDC 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.