FDA product code DBN: Fc, Antigen, Antiserum, Control

DBN is the FDA product code for fc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DBN. The average 510(k) review took 15 days (median 15).

Classification

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

Top DBN applicants

Most recent DBN clearances

Recalls for DBN devices

openFDA lists no recalls for product code DBN.

Frequently asked questions

What is FDA product code DBN?

DBN is the FDA product code for fc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel.

What device class is DBN?

Class I, regulation 21 CFR 866.5530. Typical premarket route: 510(k) exempt.

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

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

Which companies have the most DBN clearances?

Kallestad Diag, A Div. of Erbamont, Inc. (1).

Next steps

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