Data / Medical devices / Preservative, Cytological

Preservative, Cytological (LEA): 20 FDA-registered makers in 6 countries

Name: FDA-registered makers of Preservative, Cytological
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

20 establishments in 6 countries are registered with the FDA to make Preservative, Cytological (product code LEA, Class 1, 21 CFR 864.4010). 0 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on September 29, 1987, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: LEA
Device class: 1
Regulation: 864.4010
Medical specialty: Pathology

Makers by country

Country	Makers
United States	12
South Korea	3
China	2
Malaysia	1
Brazil	1
Belgium	1

Makers of Preservative, Cytological

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	Recall events	Source
Biocytech Corporation Sdn Bhd	Perak, Malaysia	Manufacturer	0	api.fda.gov
Biodyne	Seoul, South Korea	Manufacturer	0	api.fda.gov
Cellsolutions LLC	Greensboro, NC, United States	Complaint file establishment, Manufacturer for export, Specification developer	0	api.fda.gov
Celltrazone Co., Ltd	GIMPO-SI Seoul, South Korea	Manufacturer	0	api.fda.gov
Cancer Diagnostics, Inc.	Durham, NC, United States	Manufacturer	0	api.fda.gov
Hologic, Inc.	Marlborough, MA, United States	Specification developer	1	api.fda.gov
Hologic, Inc.	Londonderry, NH, United States	Manufacturer	0	api.fda.gov
Infrared Laboratory Systems dba SYNERMED	Westfield, IN, United States	Contract manufacturer	0	api.fda.gov
Kolplast Ci Ltda	Itupeva Sao Paulo, Brazil	Manufacturer	0	api.fda.gov
Lonza Walkersville, Inc.	Walkersville, MD, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Leica Biosystems Richmond, Inc.	Richmond, IL, United States	Manufacturer	1	api.fda.gov
Lonza Verviers SRL.	Verviers Liege, Belgium	Contract manufacturer	0	api.fda.gov
Richard-Allan Scientific LLC	Kalamazoo, MI, United States	Manufacturer	1	api.fda.gov
SLMP LLC d.b.a. StatLab Medical Products	McKinney, TX, United States	Manufacturer	0	api.fda.gov
SSN Solutions	Henrico, VA, United States	Manufacturer	0	api.fda.gov
Streck LLC	La Vista, NE, United States	Manufacturer	0	api.fda.gov
Wuhan Landing Intelligence Medical Co.,Ltd	Wuhan Hubei, China	Manufacturer	0	api.fda.gov
Xian Tianlong Science And Technology Co., Ltd.	Xi'an Shaanxi, China	Manufacturer	0	api.fda.gov
Yd Diagnostics	Yongin-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Zeptometrix LLC.	Buffalo, NY, United States	Manufacturer	0	api.fda.gov

Updated September 29, 1987. 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.