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MSW — System, Test, Thyroglobulin Class II

FDA Device Classification

Classification Details

Product Code
MSW
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242981siemens healthcare diagnosticsAtellica IM Thyroglobulin (Tg)June 20, 2025
K240927beckman coulterAccess ThyroglobulinJune 28, 2024
K241423beckman coulterAccess ThyroglobulinJune 7, 2024
K221890roche diagnosticsElecsys Tg IISeptember 30, 2023
K220972beckman coulterAccess ThyroglobulinSeptember 15, 2023
K031269beckman coulterACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSMay 2, 2003
K021057brahms diagnosticaBRAHMS DIAGNOSTICA DYNOTEST TG-PLUSSeptember 17, 2002
K002888nichols institute diagnosticsNICHOLS ADVANTAGE THYROGLOBOctober 20, 2000
K002905beckman coulterACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZEROctober 19, 2000
K994140nichols institute diagnosticsNICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240May 9, 2000
K991720unchangedKRONUS OPTIQUANT THYROGLOBULIN KITAugust 9, 1999
K982466diagnostic productsIMMULITE THYROGLOBULIN MODEL LKTYMarch 12, 1999
K982468diagnostic productsIMMULITE 2000 THYROGLOBULIN MODEL L2KTYMarch 12, 1999