FDA product code JZX: Equipment, Rocket Immunoelectrophoresis

JZX is the FDA product code for equipment, rocket immunoelectrophoresis. It is a Class I device, regulated under 21 CFR 866.4830 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under JZX. The average 510(k) review took 331 days (median 331).

Classification

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Recalls for JZX devices

openFDA lists no recalls for product code JZX.

Frequently asked questions

What is FDA product code JZX?

JZX is the FDA product code for equipment, rocket immunoelectrophoresis. It is a Class I device, regulated under 21 CFR 866.4830 and reviewed by the Immunology panel.

What device class is JZX?

Class I, regulation 21 CFR 866.4830. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 331 days from receipt to decision (median 331).

Which companies have the most JZX clearances?

Alko Diagnostic Corp. (1).

Next steps

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