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510(k) K982466

Device
IMMULITE THYROGLOBULIN MODEL LKTY
Applicant
DIAGNOSTIC PRODUCTS CORP.
510(k) number
K982466
Product code
MSW  
Decision
Substantially Equivalent (SESE)
Decision date
1999-03-12
Date received
1998-07-15
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
EDWARD M LEVINE
Address
5700 W. 96th St. Los Angeles CA US 90045 90045

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
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
K982468IMMULITE 2000 THYROGLOBULIN MODEL L2KTYDiagnostic Products Corp.1999-03-12

Legacy Summary#

summary

FDA Review#

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