FDA product code DCJ: Beta-Globulin, Antigen, Antiserum, Control

DCJ is the FDA product code for beta-globulin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5160 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DCJ. The average 510(k) review took 55 days (median 55).

Classification

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

Top DCJ applicants

Most recent DCJ clearances

Recalls for DCJ devices

openFDA lists no recalls for product code DCJ.

Frequently asked questions

What is FDA product code DCJ?

DCJ is the FDA product code for beta-globulin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5160 and reviewed by the Immunology panel.

What device class is DCJ?

Class I, regulation 21 CFR 866.5160. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 55 days from receipt to decision (median 55).

Which companies have the most DCJ clearances?

E.I. Dupont DE Nemours & Co., Inc. (1).

Next steps

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