Data / Medical devices / Calibrator, Primary

Calibrator, Primary (JIS): 53 FDA-registered makers in 11 countries

53 establishments in 11 countries are registered with the FDA to make Calibrator, Primary (product code JIS, Class 2, 21 CFR 862.1150). 22 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 130 510(k) clearances under this code, the latest on August 14, 2012, and lists 19 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

JIS

Device class

2

Regulation

862.1150

Medical specialty

Clinical Chemistry

Makers by country

Makers of Calibrator, Primary

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 14, 2012. 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.