FDA product code JQL: Spectrophotometric, Uroporphyrin

JQL is the FDA product code for spectrophotometric, uroporphyrin. It is a Class I device, regulated under 21 CFR 862.1790 and reviewed by the Clinical Chemistry panel. Devices under JQL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameSpectrophotometric, Uroporphyrin
Device classClass I
Regulation21 CFR 862.1790
Review panelCH — Clinical Chemistry
Medical specialtyClinical Chemistry
Premarket route510(k) exempt

Recalls for JQL devices

openFDA lists no recalls for product code JQL.

Frequently asked questions

What is FDA product code JQL?

JQL is the FDA product code for spectrophotometric, uroporphyrin. It is a Class I device, regulated under 21 CFR 862.1790 and reviewed by the Clinical Chemistry panel.

What device class is JQL?

Class I, regulation 21 CFR 862.1790. Typical premarket route: 510(k) exempt.

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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