Data / Medical devices / Agent, Clearing

Agent, Clearing (KEM): 24 FDA-registered makers in 12 countries

24 establishments in 12 countries are registered with the FDA to make Agent, Clearing (product code KEM, Class 1, 21 CFR 864.4010). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on April 5, 1988, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code

KEM

Device class

1

Regulation

864.4010

Medical specialty

Pathology

Makers by country

Makers of Agent, Clearing

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 April 5, 1988. 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.