FDA product code IDT: Apparatus, Melting Point, Paraffin
IDT is the FDA product code for apparatus, melting point, paraffin. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under IDT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for IDT devices.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Melting Point, Paraffin |
| 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 IDT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-16.
Frequently asked questions
What is FDA product code IDT?
IDT is the FDA product code for apparatus, melting point, paraffin. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDT?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Have IDT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code IDT
- Run a recall and safety report across every IDT manufacturer
- Watch product code IDT 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.