FDA product code DIG: Cholinesterase Test Paper

DIG is the FDA product code for cholinesterase test paper. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DIG. The average 510(k) review took 101 days (median 101).

Classification

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Recalls for DIG devices

openFDA lists no recalls for product code DIG.

Frequently asked questions

What is FDA product code DIG?

DIG is the FDA product code for cholinesterase test paper. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel.

What device class is DIG?

Class I, regulation 21 CFR 862.3240. Typical premarket route: 510(k) exempt.

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

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

Which companies have the most DIG clearances?

Cozart Bioscience , Ltd. (1).

Next steps

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