FDA product code DHF: D/Km-1, Antigen, Antiserum, Control

DHF is the FDA product code for d/km-1, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5065 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under DHF. The average 510(k) review took 231 days (median 231).

Classification

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

Top DHF applicants

Most recent DHF clearances

Recalls for DHF devices

openFDA lists no recalls for product code DHF.

Frequently asked questions

What is FDA product code DHF?

DHF is the FDA product code for d/km-1, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5065 and reviewed by the Pathology panel.

What device class is DHF?

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

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

Across 1 cleared submissions the average was 231 days from receipt to decision (median 231).

Which companies have the most DHF clearances?

Ventana Medical Systems, Inc. (1).

Next steps

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