FDA product code GSK: Antiserum, Francisella Tularensis

GSK is the FDA product code for antiserum, 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 GSK. The average 510(k) review took 74 days (median 74). FDA has posted 1 recall for GSK devices.

Classification

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

Top GSK applicants

Most recent GSK clearances

Recalls for GSK devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-10-20.

Frequently asked questions

What is FDA product code GSK?

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

What device class is GSK?

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

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

Across 1 cleared submissions the average was 74 days from receipt to decision (median 74).

Which companies have the most GSK clearances?

Sa Scientific, Inc. (1).

Have GSK devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2004-10-20.

Next steps

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