FDA product code DCB: Fab, Fitc, Antigen, Antiserum, Control

DCB is the FDA product code for fab, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5520 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DCB. The average 510(k) review took 13 days (median 13).

Classification

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

Top DCB applicants

Most recent DCB clearances

Recalls for DCB devices

openFDA lists no recalls for product code DCB.

Frequently asked questions

What is FDA product code DCB?

DCB is the FDA product code for fab, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5520 and reviewed by the Immunology panel.

What device class is DCB?

Class I, regulation 21 CFR 866.5520. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 13 days from receipt to decision (median 13).

Which companies have the most DCB clearances?

Kallestad Laboratories, Inc. (1).

Next steps

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