FDA product code DMX: Liquid Chromatography, Salicylate

DMX is the FDA product code for liquid chromatography, salicylate. It is a Class II device, regulated under 21 CFR 862.3830 and reviewed by the Clinical Toxicology panel. Devices under DMX reach the market by 510(k); FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameLiquid Chromatography, Salicylate
Device classClass II
Regulation21 CFR 862.3830
Review panelTX — Clinical Toxicology
Medical specialtyClinical Toxicology
Premarket route510(k)
Third-party 510(k) review eligibleYes

Recalls for DMX devices

openFDA lists no recalls for product code DMX.

Frequently asked questions

What is FDA product code DMX?

DMX is the FDA product code for liquid chromatography, salicylate. It is a Class II device, regulated under 21 CFR 862.3830 and reviewed by the Clinical Toxicology panel.

What device class is DMX?

Class II, regulation 21 CFR 862.3830. Typical premarket route: 510(k).

Next steps

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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