FDA.reportPublic FDA data

510(k) K243570

Device
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
Applicant
Siemens Healthcare Diagnostics
510(k) number
K243570
Product code
JLW
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-25
Date received
2024-11-18
Regulation
862.1690
Classification name
Radioimmunoassay, Thyroid-Stimulating Hormone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Yevgenia Sarkisian
Address
500 Gbc Dr. Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JLW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.2026-02-06
K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.2024-07-22
K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.2024-04-04
K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.2023-07-13
K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.2022-11-10
K190773Elecsys TSHRoche Diagnostics2019-04-16
K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc.2017-10-13
K171103Lumipulse G TSH-III Immunoreaction CartridgesFujirebio Diagnostics,Inc.2017-07-28
K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.2017-07-14
K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics2017-01-23
K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlSysmex America, Inc.2016-10-21
K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc.2016-08-18
K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc.2016-05-31
K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc.2015-11-20
K150403ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc.2015-05-01