FDA product code IFS: Solution, Helly
IFS is the FDA product code for solution, helly. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Hematology panel. Devices under IFS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Helly |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | HE — Hematology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IFS devices
openFDA lists no recalls for product code IFS.
Frequently asked questions
What is FDA product code IFS?
IFS is the FDA product code for solution, helly. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Hematology panel.
What device class is IFS?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IFS
- Run a recall and safety report across every IFS manufacturer
- Watch product code IFS 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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