Data / Medical devices / Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG): 252 FDA-registered makers in 28 countries

252 establishments in 28 countries are registered with the FDA to make Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (product code LXG, Class 1, 21 CFR 862.2050). 0 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on July 12, 2002, and lists 18 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

LXG

Device class

1

Regulation

862.2050

Medical specialty

Clinical Chemistry

Makers by country

Makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated July 12, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.