FDA product code IDN: Microtome, Freezing Attachment
IDN is the FDA product code for microtome, freezing attachment. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under IDN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Microtome, Freezing Attachment |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IDN devices
openFDA lists no recalls for product code IDN.
Frequently asked questions
What is FDA product code IDN?
IDN is the FDA product code for microtome, freezing attachment. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDN?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IDN
- Run a recall and safety report across every IDN manufacturer
- Watch product code IDN 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.