FDA.reportPublic FDA data

510(k) K213517

Device
Access Thyroglobulin Antibody II
Applicant
Beckman Coulter, Inc.
510(k) number
K213517
Product code
JZO
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-26
Date received
2021-11-03
Regulation
866.5870
Classification name
System, Test, Thyroid Autoantibody
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Abhi Kannan
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 JZO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.2025-10-17
K240469Access TPO AntibodyBeckman Coulter, Inc.2024-08-09
K222610Elecsys Anti-TgRoche Diagnostics2023-09-15
K193313Elecsys Anti-TSHRRoche Diagnostics2020-02-27
K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB2016-03-25
K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.2016-03-03
K092229THYRETAIN TM TSI REPORTER BIOASSAYDiagnostic Hybrids, Inc.2010-05-18
K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120Theratest Laboratories, Inc.2009-09-03
K083391THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAYDiagnostic Hybrids, Inc.2009-05-21
K080092ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROABRoche Diagnostics Corp.2008-07-28
K080159KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KITKronus Market Development Associates, Inc.2008-05-22
K061794FIDIS TM THYRO, MODEL MX002Biomedical Diagnostics (Bmd) SA2006-11-21
K052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSFisher Diagnostics2006-07-18
K061382ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227Beckman Coulter, Inc.2006-07-06
K052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMFisher Diagnostics2006-05-10