FDA product code GMA: Antisera, Fluorescent, Sporothrix Schenekii

GMA is the FDA product code for antisera, fluorescent, sporothrix schenekii. It is a Class I device, regulated under 21 CFR 866.3680 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GMA. The average 510(k) review took 25 days (median 25).

Classification

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

Top GMA applicants

Most recent GMA clearances

Recalls for GMA devices

openFDA lists no recalls for product code GMA.

Frequently asked questions

What is FDA product code GMA?

GMA is the FDA product code for antisera, fluorescent, sporothrix schenekii. It is a Class I device, regulated under 21 CFR 866.3680 and reviewed by the Microbiology panel.

What device class is GMA?

Class I, regulation 21 CFR 866.3680. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 25 days from receipt to decision (median 25).

Which companies have the most GMA clearances?

Immuno-Mycologics, Inc. (1).

Next steps

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