FDA product code IBC: Diastase
IBC is the FDA product code for diastase. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel. Devices under IBC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Diastase |
| Device class | Class I |
| Regulation | 21 CFR 864.4400 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Recalls for IBC devices
openFDA lists no recalls for product code IBC.
Frequently asked questions
What is FDA product code IBC?
IBC is the FDA product code for diastase. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel.
What device class is IBC?
Class I, regulation 21 CFR 864.4400. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IBC
- Run a recall and safety report across every IBC manufacturer
- Watch product code IBC 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.