FDA product code IAA: Titan Yellow
IAA is the FDA product code for titan yellow. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under IAA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Titan Yellow |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IAA devices
openFDA lists no recalls for product code IAA.
Frequently asked questions
What is FDA product code IAA?
IAA is the FDA product code for titan yellow. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is IAA?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IAA
- Run a recall and safety report across every IAA manufacturer
- Watch product code IAA 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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