FDA product code GSJ: Antiserum, Fluorescent, Francisella Tularensis

GSJ is the FDA product code for antiserum, fluorescent, francisella tularensis. It is a Class II device, regulated under 21 CFR 866.3280 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GSJ. The average 510(k) review took 21 days (median 21).

Classification

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

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Most recent GSJ clearances

Recalls for GSJ devices

openFDA lists no recalls for product code GSJ.

Frequently asked questions

What is FDA product code GSJ?

GSJ is the FDA product code for antiserum, fluorescent, francisella tularensis. It is a Class II device, regulated under 21 CFR 866.3280 and reviewed by the Microbiology panel.

What device class is GSJ?

Class II, regulation 21 CFR 866.3280. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).

Which companies have the most GSJ clearances?

Marlo Surgical Technology (1).

Next steps

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