FDA product code GPF: Antigen, Agglutinating, Echinococcus Spp.

GPF is the FDA product code for antigen, agglutinating, echinococcus spp.. It is a Class I device, regulated under 21 CFR 866.3200 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GPF. The average 510(k) review took 49 days (median 49).

Classification

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

Top GPF applicants

Most recent GPF clearances

Recalls for GPF devices

openFDA lists no recalls for product code GPF.

Frequently asked questions

What is FDA product code GPF?

GPF is the FDA product code for antigen, agglutinating, echinococcus spp.. It is a Class I device, regulated under 21 CFR 866.3200 and reviewed by the Microbiology panel.

What device class is GPF?

Class I, regulation 21 CFR 866.3200. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).

Which companies have the most GPF clearances?

Volu Sol Medical Industries (1).

Next steps

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