FDA product code IAT: Syrup, Gum, Apathy'S
IAT is the FDA product code for syrup, gum, apathy's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under IAT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Syrup, Gum, Apathy'S |
| 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 IAT devices
openFDA lists no recalls for product code IAT.
Frequently asked questions
What is FDA product code IAT?
IAT is the FDA product code for syrup, gum, apathy's. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IAT?
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 IAT
- Run a recall and safety report across every IAT manufacturer
- Watch product code IAT 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.