FDA product code FLJ: Unit, Airflow, Laminar
FLJ is the FDA product code for unit, airflow, laminar. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General Hospital panel. Devices under FLJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Airflow, Laminar |
| Device class | Class II |
| Regulation | 21 CFR 878.5070 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for FLJ devices
openFDA lists no recalls for product code FLJ.
Frequently asked questions
What is FDA product code FLJ?
FLJ is the FDA product code for unit, airflow, laminar. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General Hospital panel.
What device class is FLJ?
Class II, regulation 21 CFR 878.5070. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FLJ
- Run a recall and safety report across every FLJ manufacturer
- Watch product code FLJ 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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