Data / Medical devices / Separator, Automated, Blood Cell, Diagnostic

Separator, Automated, Blood Cell, Diagnostic (GKT): 23 FDA-registered makers in 9 countries

23 establishments in 9 countries are registered with the FDA to make Separator, Automated, Blood Cell, Diagnostic (product code GKT, Class 2, 21 CFR 864.9245). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on September 11, 2020, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

GKT

Device class

2

Regulation

864.9245

Medical specialty

Hematology

Makers by country

Makers of Separator, Automated, Blood Cell, Diagnostic

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 September 11, 2020. 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.