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Data / Medical devices / Canada / DiaSorin Canada Inc.

DiaSorin Canada Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 1 510(k) clearance

DiaSorin Canada Inc. is registered with the FDA (registration 3012449645) in Mississauga Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 29, 2010. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3012449645
Address
5075 Whittle Road Suite 210 & 140, Mississauga Ontario, Canada, L4Z 3N1
Owner or operator
DiaSorin Inc. (9051149)
Roles
Exporter to the US
First device listed
March 31, 2017
Registered through
2027
Brand names listed
LIAISON MDX

Devices it lists

DeviceProduct codeClassRoleSource
Real Time Nucleic Acid Amplification SystemOOI2Exporter to the USaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 29, 2010K1023143M INTEGRATED CYCLER (110V) & (220V)OOISubstantially EquivalentFocus Diagnostics, Inc.accessdata.fda.gov

Compare with other makers

Updated October 29, 2010. 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.