FDA product code ICJ: Carbol Night Blue

ICJ is the FDA product code for carbol night blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under ICJ. The average 510(k) review took 15 days (median 15).

Classification

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

Top ICJ applicants

Most recent ICJ clearances

Recalls for ICJ devices

openFDA lists no recalls for product code ICJ.

Frequently asked questions

What is FDA product code ICJ?

ICJ is the FDA product code for carbol night blue. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.

What device class is ICJ?

Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 15 days from receipt to decision (median 15).

Which companies have the most ICJ clearances?

Bd Becton Dickinson Vacutainer Systems Preanalytic (1).

Next steps

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