Data / Medical devices / Instrument, Hematocrit, Automated

Instrument, Hematocrit, Automated (GKF): 17 FDA-registered makers in 7 countries

Name: FDA-registered makers of Instrument, Hematocrit, Automated
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 7 countries are registered with the FDA to make Instrument, Hematocrit, Automated (product code GKF, Class 2, 21 CFR 864.5600). 1 of them has 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 December 14, 2016, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: GKF
Device class: 2
Regulation: 864.5600
Medical specialty: Hematology

Makers by country

Country	Makers
United States	11
China	1
Netherlands	1
Denmark	1
Switzerland	1
Poland	1
United Kingdom	1

Makers of Instrument, Hematocrit, Automated

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.

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Instrumentation Laboratory Co.	Bedford, MA, United States	Manufacturer	1	December 14, 2016	api.fda.gov
Bionostics, Inc.	Devens, MA, United States	Contract manufacturer	0		api.fda.gov
Edan Instruments, Inc.	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Eurotrol B.V.	EDE Gelderland, Netherlands	Contract manufacturer	0		api.fda.gov
Instrumentation Laboratory Co.	Orangeburg, NY, United States	Manufacturer, Repackager or relabeler	0		api.fda.gov
James Alexander Corp.	Blairstown, NJ, United States	Contract manufacturer	0		api.fda.gov
Medica Corp.	Bedford, MA, United States	Manufacturer	0		api.fda.gov
Nova Biomedical Corporation	Waltham, MA, United States	Complaint file establishment, Manufacturer, Remanufacturer	0		api.fda.gov
Nova Biomedical Corporation	Billerica, MA, United States	Manufacturer, Remanufacturer	0		api.fda.gov
Radiometer Medical Aps	BROENSHOEJ Hovedstaden, Denmark	Complaint file establishment, Manufacturer	0		api.fda.gov
Roche Diagnostics International Ltd.	ROTKREUZ Zug, Switzerland	Manufacturer	0		api.fda.gov
Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, Poland	Contract manufacturer	0		api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd	SUDBURY Suffolk, United Kingdom	Manufacturer, Specification developer	0		api.fda.gov
Stanbio Laboratory	Boerne, TX, United States	Manufacturer, Repackager or relabeler, Specification developer	0		api.fda.gov
Siemens Healthcare Diagnostics Inc	East Walpole, MA, United States	Complaint file establishment, Specification developer	0		api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	0		api.fda.gov
Siemens Healthcare Diagnostics Inc.	E Walpole, MA, United States	Manufacturer	0		api.fda.gov

Updated December 14, 2016. 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.