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510(k) K031269

Device
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant
BECKMAN COULTER, INC.
510(k) number
K031269
Product code
MSW  
Decision
Substantially Equivalent (SESE)
Decision date
2003-05-02
Date received
2003-04-21
Regulation
866.6010
Classification name
System, Test, Thyroglobulin
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LYNN WEIST
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 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
K221890Elecsys Tg IIRoche Diagnostics2023-09-30
K220972Access ThyroglobulinBeckman Coulter, Inc.2023-09-15
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

Legacy Summary#

summary

FDA Review#

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