FDA product code DHY: Ng4m(A), Antigen, Antiserum, Control

DHY is the FDA product code for ng4m(a), 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 DHY. The average 510(k) review took 101 days (median 101).

Classification

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

Top DHY applicants

Most recent DHY clearances

Recalls for DHY devices

openFDA lists no recalls for product code DHY.

Frequently asked questions

What is FDA product code DHY?

DHY is the FDA product code for ng4m(a), 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 DHY?

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

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

Across 1 cleared submissions the average was 101 days from receipt to decision (median 101).

Which companies have the most DHY clearances?

Clintox Laboratories, Inc. (1).

Next steps

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