FDA product code LAY: Methotrexate Control Materials
LAY is the FDA product code for methotrexate control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. Devices under LAY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Methotrexate Control Materials |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Recalls for LAY devices
openFDA lists no recalls for product code LAY.
Frequently asked questions
What is FDA product code LAY?
LAY is the FDA product code for methotrexate control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is LAY?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code LAY
- Run a recall and safety report across every LAY manufacturer
- Watch product code LAY 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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