FDA product code LOQ: Device, General Purpose, Hematology

LOQ is the FDA product code for device, general purpose, hematology. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under LOQ. The average 510(k) review took 64 days (median 64). FDA has posted 1 recall for LOQ devices.

Classification

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

Top LOQ applicants

Most recent LOQ clearances

Recalls for LOQ devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-04-17.

Frequently asked questions

What is FDA product code LOQ?

LOQ is the FDA product code for device, general purpose, hematology. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Hematology panel.

What device class is LOQ?

Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 64 days from receipt to decision (median 64).

Which companies have the most LOQ clearances?

Chiron Diagnostics Corp. (1).

Have LOQ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2006-04-17.

Next steps

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