FDA product code JNF: Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen

JNF is the FDA product code for ion-exchange resin, ehrlich's reagent, porphobilinogen. It is a Class I device, regulated under 21 CFR 862.1590 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JNF. The average 510(k) review took 203 days (median 203).

Classification

Compare with all 510(k) review times · Search every JNF clearance

Top JNF applicants

Most recent JNF clearances

Recalls for JNF devices

openFDA lists no recalls for product code JNF.

Frequently asked questions

What is FDA product code JNF?

JNF is the FDA product code for ion-exchange resin, ehrlich's reagent, porphobilinogen. It is a Class I device, regulated under 21 CFR 862.1590 and reviewed by the Clinical Chemistry panel.

What device class is JNF?

Class I, regulation 21 CFR 862.1590. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code JNF?

Across 1 cleared submissions the average was 203 days from receipt to decision (median 203).

Which companies have the most JNF clearances?

Trace America, Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code JNF
• Run a recall and safety report across every JNF manufacturer
• Watch product code JNF 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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