FDA product code KSJ: System, Identification, Hepatitis B Antigen
KSJ is the FDA product code for system, identification, hepatitis b antigen. It is a Class III device, reviewed by the Hematology panel. Devices under KSJ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Identification, Hepatitis B Antigen |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for KSJ devices
openFDA lists no recalls for product code KSJ.
Frequently asked questions
What is FDA product code KSJ?
KSJ is the FDA product code for system, identification, hepatitis b antigen. It is a Class III device, reviewed by the Hematology panel.
What device class is KSJ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KSJ
- Run a recall and safety report across every KSJ manufacturer
- Watch product code KSJ 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.