FDA.reportPublic FDA data

510(k) K242095

Device
Access Toxo IgM II
Applicant
Beckman Coulter, Inc.
510(k) number
K242095
Product code
LGD
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-11
Date received
2024-07-17
Regulation
866.3780
Classification name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stefanie K Berg
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LGD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242022Access Toxo IgGBeckman Coulter, Inc.2025-03-28
K233932Alinity i Toxo IgMAbbott Laboratories2024-08-30
K210596ARCHITECT Toxo IgGAbbott Laboratories2022-05-19
K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics2017-06-23
K142826ADVIA Centaur Toxoplasma M (Toxo M)Siemens Healthcare Diagnostics, Inc.2015-12-22
K132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, Inc.2013-08-28
K131441LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM IIDiaSorin, Inc.2013-08-09
K101946VIDAS TOXO IGG AVIDITYbioMerieux, Inc.2011-05-18
K102681ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)Siemens Healthcare Diagnostics, Inc.2011-05-04
K090847PLATELIA TOXO IGM KIT MODEL 26211Bio-Rad Laboratories2009-07-01
K073501ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGGRoche Diagnostics Corp.2008-06-09
K080869ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QCBeckman Coulter, Inc.2008-05-23
K052499DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYSDiasorin S.P.A2006-02-08
K032162ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAYBeckman Coulter, Inc.2003-08-08
K031506ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAYBeckman Coulter, Inc.2003-06-02