FDA product code GSL: Antigens, Slide And Tube, Francisella Tularensis

GSL is the FDA product code for antigens, slide and tube, 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 GSL. The average 510(k) review took 70 days (median 70).

Classification

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

Top GSL applicants

Most recent GSL clearances

Recalls for GSL devices

openFDA lists no recalls for product code GSL.

Frequently asked questions

What is FDA product code GSL?

GSL is the FDA product code for antigens, slide and tube, francisella tularensis. It is a Class II device, regulated under 21 CFR 866.3280 and reviewed by the Microbiology panel.

What device class is GSL?

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

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

Across 1 cleared submissions the average was 70 days from receipt to decision (median 70).

Which companies have the most GSL clearances?

Sa Scientific, Inc. (1).

Next steps

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