FDA product code DHI: Ng3m(Bo), Antigen, Antiserum, Control

DHI is the FDA product code for ng3m(bo), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5065 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DHI. The average 510(k) review took 18 days (median 18).

Classification

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

Top DHI applicants

Most recent DHI clearances

Recalls for DHI devices

openFDA lists no recalls for product code DHI.

Frequently asked questions

What is FDA product code DHI?

DHI is the FDA product code for ng3m(bo), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5065 and reviewed by the Immunology panel.

What device class is DHI?

Class I, regulation 21 CFR 866.5065. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 18 days from receipt to decision (median 18).

Which companies have the most DHI clearances?

Serono Laboratories, Inc. (1).

Next steps

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