FDA product code DET: Lactic Dehydrogenase, Antigen, Antiserum, Control

DET is the FDA product code for lactic dehydrogenase, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5560 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DET. The average 510(k) review took 9 days (median 9).

Classification

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

Top DET applicants

Most recent DET clearances

Recalls for DET devices

openFDA lists no recalls for product code DET.

Frequently asked questions

What is FDA product code DET?

DET is the FDA product code for lactic dehydrogenase, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5560 and reviewed by the Immunology panel.

What device class is DET?

Class I, regulation 21 CFR 866.5560. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 9 days from receipt to decision (median 9).

Which companies have the most DET clearances?

Boehringer Mannheim Corp. (1).

Next steps

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