FDA product code JOC: Colorimetric, Xylose

JOC is the FDA product code for colorimetric, xylose. It is a Class I device, regulated under 21 CFR 862.1820 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JOC. The average 510(k) review took 51 days (median 51).

Classification

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

Top JOC applicants

Most recent JOC clearances

Recalls for JOC devices

openFDA lists no recalls for product code JOC.

Frequently asked questions

What is FDA product code JOC?

JOC is the FDA product code for colorimetric, xylose. It is a Class I device, regulated under 21 CFR 862.1820 and reviewed by the Clinical Chemistry panel.

What device class is JOC?

Class I, regulation 21 CFR 862.1820. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).

Which companies have the most JOC clearances?

Great Smokies Diagnostic Laboratory (1).

Next steps

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