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510(k) K221890

Device
Elecsys Tg II
Applicant
Roche Diagnostics
510(k) number
K221890
Product code
MSW
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-30
Date received
2022-06-29
Regulation
866.6010
Classification name
System, Test, Thyroglobulin
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Edie Eads
Address
9115 Hague Rd. Indianapolis IN US 42650 42650

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.2025-06-20
K240927Access ThyroglobulinBeckman Coulter, Inc.2024-06-28
K241423Access ThyroglobulinBeckman Coulter, Inc.2024-06-07
K220972Access ThyroglobulinBeckman Coulter, Inc.2023-09-15
K031269ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc.2003-05-02
K021057BRAHMS DIAGNOSTICA DYNOTEST TG-PLUSBrahms Diagnostica, LLC2002-09-17
K002888NICHOLS ADVANTAGE THYROGLOBNichols Institute Diagnostics2000-10-20
K002905ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZERBeckman Coulter, Inc.2000-10-19
K994140NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240Nichols Institute Diagnostics2000-05-09
K991720KRONUS OPTIQUANT THYROGLOBULIN KITUnchanged1999-08-09
K982466IMMULITE THYROGLOBULIN MODEL LKTYDiagnostic Products Corp.1999-03-12
K982468IMMULITE 2000 THYROGLOBULIN MODEL L2KTYDiagnostic Products Corp.1999-03-12