Data / Medical devices / United Kingdom / Shandon Diagnostics Limited

Shandon Diagnostics Limited: FDA-registered device maker in RUNCORN Cheshire East, United Kingdom, 1 510(k) clearance

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

Shandon Diagnostics Limited is registered with the FDA (registration 3003584784) in RUNCORN Cheshire East, United Kingdom. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003584784
Address: Tudor Road Manor Park, RUNCORN Cheshire East, United Kingdom, WA7 1TA
Owner or operator: Epredia Holdings Ltd. (10062642)
Roles: Complaint file establishment, Manufacturer
First device listed: February 28, 2020
Registered through: 2026
Brand names listed: Autostainer 360, Autostainer 480S, Autostainer 720, Bionet cassettes in stripped stacks (aqua) 25x40 with front lid, Bionet cassettes in stripped stacks (beige) 25x40 with front lid, Bionet cassettes in stripped stacks (blue) 25x40 with front lid, Bionet cassettes in stripped stacks (green) 25x40 with front lid, Bionet cassettes in stripped stacks (grey) 25x40 with front lid and more

Devices it lists

Device	Product code	Class	Role	Source
Bath, Flotation, Tissue	IDY	1	Manufacturer	accessdata.fda.gov
Bath, Incubators/Water, All	JTQ	1	Manufacturer	accessdata.fda.gov
Cassettes, Tissue	IDZ	1	Manufacturer	accessdata.fda.gov
Device For Sealing Microsections	KIM	1	Manufacturer	accessdata.fda.gov
Digital Pathology Display	PZZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Digital Pathology Image Viewing And Management Software	QKQ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Dispensers, Paraffin	IDW	1	Manufacturer	accessdata.fda.gov
Filters, Cell Collection, Tissue Processing	KET	1	Manufacturer	accessdata.fda.gov
Microtome, Cryostat	IDP	1	Manufacturer	accessdata.fda.gov
Microtome, Rotary	IDO	1	Manufacturer	accessdata.fda.gov
Microtome, Sliding	KFL	1	Manufacturer	accessdata.fda.gov
Processor, Tissue, Automated	IEO	1	Manufacturer	accessdata.fda.gov
Slide Stainer, Automated	KPA	1	Manufacturer	accessdata.fda.gov
Slide Stainer, Immersion Type	KIO	1	Manufacturer	accessdata.fda.gov
Whole Slide Imaging System	PSY	2	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
February 28, 2025	K241717	E1000 Dx Digital Pathology Solution	PSY	Substantially Equivalent	Shandon Diagnostics Limited	accessdata.fda.gov

Compare with other makers

Updated February 28, 2025. 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.