FDA product code MLH: Strip, Hama Igg, Elisa, In Vitro Test System
MLH is the FDA product code for strip, hama igg, elisa, in vitro test system. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. Devices under MLH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Strip, Hama Igg, Elisa, In Vitro Test System |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MLH devices
openFDA lists no recalls for product code MLH.
Frequently asked questions
What is FDA product code MLH?
MLH is the FDA product code for strip, hama igg, elisa, in vitro test system. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is MLH?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MLH
- Run a recall and safety report across every MLH manufacturer
- Watch product code MLH 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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