FDA product code LIA: Antigens, All Groups, Shigella Spp.

LIA is the FDA product code for antigens, all groups, shigella spp.. It is a Class II device, regulated under 21 CFR 866.3660 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under LIA. The average 510(k) review took 16 days (median 16). FDA has posted 1 recall for LIA devices.

Classification

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

Top LIA applicants

Most recent LIA clearances

Recalls for LIA devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-01-25.

Frequently asked questions

What is FDA product code LIA?

LIA is the FDA product code for antigens, all groups, shigella spp.. It is a Class II device, regulated under 21 CFR 866.3660 and reviewed by the Microbiology panel.

What device class is LIA?

Class II, regulation 21 CFR 866.3660. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 16 days from receipt to decision (median 16).

Which companies have the most LIA clearances?

Lab Ability, Inc. (1).

Have LIA devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2010-01-25.

Next steps

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