FDA product code IFZ: Gelatin For Specimen Adhesion

IFZ is the FDA product code for gelatin for specimen adhesion. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IFZ. The average 510(k) review took 6 days (median 6).

Classification

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

Top IFZ applicants

Most recent IFZ clearances

Recalls for IFZ devices

openFDA lists no recalls for product code IFZ.

Frequently asked questions

What is FDA product code IFZ?

IFZ is the FDA product code for gelatin for specimen adhesion. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.

What device class is IFZ?

Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 6 days from receipt to decision (median 6).

Which companies have the most IFZ clearances?

Surgipath Medical Industries, Inc. (1).

Next steps

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