FDA product code KHT: Fraction V, Antigen, Antiserum, Control

KHT is the FDA product code for fraction v, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5370 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under KHT. The average 510(k) review took 18 days (median 18).

Classification

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

Top KHT applicants

Most recent KHT clearances

Recalls for KHT devices

openFDA lists no recalls for product code KHT.

Frequently asked questions

What is FDA product code KHT?

KHT is the FDA product code for fraction v, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5370 and reviewed by the Immunology panel.

What device class is KHT?

Class I, regulation 21 CFR 866.5370. Typical premarket route: 510(k) exempt.

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

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

Which companies have the most KHT clearances?

Norwich Eaton Pharmaceuticals, Inc. (1).

Next steps

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