FDA product code IFJ: Fixative, Richardson Glycol
IFJ is the FDA product code for fixative, richardson glycol. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under IFJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fixative, Richardson Glycol |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IFJ devices
openFDA lists no recalls for product code IFJ.
Frequently asked questions
What is FDA product code IFJ?
IFJ is the FDA product code for fixative, richardson glycol. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IFJ?
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 IFJ
- Run a recall and safety report across every IFJ manufacturer
- Watch product code IFJ 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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