FDA product code IBG: Trypsin

IBG is the FDA product code for trypsin. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under IBG, from 2 different applicants. The average 510(k) review took 34 days (median 34). FDA has posted 1 recall for IBG devices.

Classification

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

Top IBG applicants

Most recent IBG clearances

Recalls for IBG devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-02.

Frequently asked questions

What is FDA product code IBG?

IBG is the FDA product code for trypsin. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Pathology panel.

What device class is IBG?

Class I, regulation 21 CFR 864.4400. Typical premarket route: 510(k) exempt.

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

Across 2 cleared submissions the average was 34 days from receipt to decision (median 34).

Which companies have the most IBG clearances?

Oxoid U.S.A., Inc. (1); Flow Laboratories, Inc. (1).

Have IBG devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2018-08-02.

Next steps

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