FDA product code SES: Non-Factor Replacement Product Test System
SES is the FDA product code for non-factor replacement product test system. It is a Class II device, regulated under 21 CFR 864.7298 and reviewed by the Hematology panel. Devices under SES reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products that are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with bleeding disorders, including hemophilia, in human blood specimens to ensure appropriate therapy in accordance with the approved non-factor replacement product labeling.
Classification
| Field | Value |
|---|---|
| Device name | Non-Factor Replacement Product Test System |
| Device class | Class II |
| Regulation | 21 CFR 864.7298 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for SES devices
openFDA lists no recalls for product code SES.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J7193 — Factor ix (antihemophilic factor, purified, non-recombinant) per i.u.
Frequently asked questions
What is FDA product code SES?
SES is the FDA product code for non-factor replacement product test system. It is a Class II device, regulated under 21 CFR 864.7298 and reviewed by the Hematology panel.
What device class is SES?
Class II, regulation 21 CFR 864.7298. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SES
- Run a recall and safety report across every SES manufacturer
- Watch product code SES 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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