Data / Medical devices / United States / Cellsolutions LLC

Cellsolutions LLC: FDA-registered device maker in Greensboro, NC, United States, 3 510(k) clearances

Name: Cellsolutions LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cellsolutions LLC is registered with the FDA (registration 3009034535) in Greensboro, NC, United States. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 9, 2009. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009034535
Address: 1100 Revolution Mill Dr, Greensboro, NC, United States, 27405
Owner or operator: CellSolutions LLC (10045470)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
First device listed: November 20, 2013
Registered through: 2026
Brand names listed: BTA C-101A General Cytology Preservative, BestCyte Image Display and Training System, BestPrep General Cytology Preservative, CS30, CellSolutions Filter Kit, CellSolutions Red Lytic General Cytology Preservative, CellSolutions Slides, CellSolutions Small Filter Kit and more

Devices it lists

Device	Product code	Class	Role	Source
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Complaint file establishment	accessdata.fda.gov
Cytology Kit	OKY	2	Complaint file establishment	accessdata.fda.gov
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System	NVV	1	Complaint file establishment	accessdata.fda.gov
Filters, Cell Collection, Tissue Processing	KET	1	Complaint file establishment, Specification developer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Preservative, Cytological	LEA	1	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov
Processor, Tissue, Automated	IEO	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Slides, Microscope	KEW	1	Complaint file establishment	accessdata.fda.gov
Spatula, Cervical, Cytological	HHT	2	Complaint file establishment	accessdata.fda.gov
Station, Pipetting And Diluting, For Clinical Use	JQW	1	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 9, 2009	K083012	PAPCONE	HHT	Substantially Equivalent	Otto Bock Pur Life Science GmbH	accessdata.fda.gov
February 2, 2005	K043369	CERVEX-BRUSH COMBI	HHT	Substantially Equivalent	Rovers Medical Devices B.V.	accessdata.fda.gov
May 24, 1994	K930955	CERVEX-BRUSH	HHT	Substantially Equivalent	Rovers B.V.	accessdata.fda.gov

Compare with other makers

Updated April 9, 2009. 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.