FDA product code MTK: Kit, Sample Collection, Hiv
MTK is the FDA product code for kit, sample collection, hiv. It is a Class III device, reviewed by the Hematology panel. Devices under MTK reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Sample Collection, Hiv |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MTK devices
openFDA lists no recalls for product code MTK.
Frequently asked questions
What is FDA product code MTK?
MTK is the FDA product code for kit, sample collection, hiv. It is a Class III device, reviewed by the Hematology panel.
What device class is MTK?
Class III. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MTK
- Run a recall and safety report across every MTK manufacturer
- Watch product code MTK 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.