Data / Medical devices / Calibrators, Drug Specific

Calibrators, Drug Specific (DLJ): 31 FDA-registered makers in 7 countries

31 establishments in 7 countries are registered with the FDA to make Calibrators, Drug Specific (product code DLJ, Class 2, 21 CFR 862.3200). 6 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 123 510(k) clearances under this code, the latest on August 8, 2013, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

DLJ

Device class

2

Regulation

862.3200

Medical specialty

Clinical Toxicology

Makers by country

Makers of Calibrators, Drug Specific

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 August 8, 2013. 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.