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Panels › Clinical Chemistry › Product code JLW · Class 2

Radioimmunoassay, Thyroid-Stimulating Hormone

Regulation 862.1690

1510(k)s in 12 months (242 all time)
1recalls in 12 months (46 all time)
44recalls that name a 510(k)
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Top companies in JLW

Company510(k)sRecalls
Siemens Healthcare Diagnostics1028
Abbott Laboratories100
Bd Becton Dickinson Vacutainer Systems Preanalytic90
Bio-Rad90
Beckman Coulter, Inc.44
Diagnostic Products Corp.80
Micromedic Systems80
Corning Medical & Scientific70
Ortho-Clinical Diagnostics24
Amersham Corp.50
Decided510(k)Device and applicantCode
Feb 6, 2026K251543Atellica® IM TSH3-Ultra II (TSH3ULII)
Siemens Healthcare Diagnostics, Inc.
JLW
Apr 25, 2025K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent car
Siemens Healthcare Diagnostics
JLW
Jul 22, 2024K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
Genalyte, Inc.
JLW
Apr 4, 2024K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
Siemens Healthcare Diagnostics, Inc.
JLW
Jul 13, 2023K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
Siemens Healthcare Diagnostics, Inc.
JLW
Nov 10, 2022K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc.
JLW
Apr 16, 2019K190773Elecsys TSH
Roche Diagnostics
JLW
Oct 13, 2017K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
Boditech Med, Inc., KR
JLW
Jul 28, 2017K171103Lumipulse G TSH-III Immunoreaction Cartridges
Fujirebio Diagnostics,Inc.
JLW
Jul 14, 2017K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
Shenzhen New Industries Biomedical Engineering Co., Ltd., CN
JLW
Jan 23, 2017K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzer
Roche Diagnostics
JLW
Oct 21, 2016K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
Sysmex America, Inc.
JLW
Aug 18, 2016K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
Beckman Coulter, Inc.
JLW
May 31, 2016K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
Siemens Healthcare Diagnostics, Inc.
JLW
Nov 20, 2015K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
Siemens Healthcare Diagnostics, Inc.
JLW
May 1, 2015K150403ADVIA Centaur TSH3-Ultra
Siemens Healthcare Diagnostics, Inc.
JLW
Apr 22, 2015K141999ADVIA CENTAUR TSH
Siemens Healthcare Diagnostics, Inc.
JLW
Mar 14, 2014K131928FREND TSH (REAGENT CARTRIDGE)
Nanoentek USA, Inc.
JLW
Apr 5, 2013K130469LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
DiaSorin, Inc.
JLW
Mar 9, 2012K110761MICT TSH
Magnabiosciences, LLC
JLW
Aug 13, 2010K101390FASTPACK TSH IMMUNOASSAY
Qualigen, Inc.
JLW
Sep 3, 2009K090846GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
Perkinelmer, Inc.
JLW
May 8, 2009K083844ADVIA CENTAUR TSH3-ULTRA METHOD
Siemens Healthcare Diagnostics
JLW
Dec 22, 2008K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
Ortho-Clinical Diagnostics
JLW
Oct 23, 2008K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
Ortho-Clinical Diagnostics, Inc.
JLW
May 23, 2008K081074DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
Siemens Healthcare Diagnostics, Inc.
JLW
Apr 10, 2008K072458GBI TSH NEONATAL SCREENING KIT
Golden Bridge International, Inc.
JLW
Apr 4, 2008K063437ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300
Monobind, Inc.
JLW
Nov 29, 2006K062581OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
Olympus America, Inc.
JLW
Feb 27, 2006K060090DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
JLW
Jan 4, 2006K052301FASTPACK TSH IMMUNOASSAY
Qualigen, Inc.
JLW
Sep 16, 2004K042281MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
Beckman Coulter, Inc.
JLW
Jul 14, 2004K041014TSH-CTK-3 IRMA
DiaSorin, Inc.
JLW
Jul 25, 2003K030912THYRO TEST
Thryotec
JLW
Nov 25, 2002K023093ACCESS HYPERSENSITIVE HTSH ASSAY
Beckman Coulter, Inc.
JLW
Jul 19, 2002K013420CHEMWELL, ALSO KNOWN AS PROJECT 2900
Awareness Technology, Inc.
JLW
Aug 7, 2001K011527PRAXSYS RELIA TSH TEST
Praxsys Biosystems, Inc.
JLW
Jul 16, 2001K011525SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
Biosafe Laboratories, Inc.
JLW
Mar 23, 2001K003752BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)
Biosafe Laboratories, Inc.
JLW
Nov 2, 2000K001455ACCUWELL TSH, MODEL KAW-TSH-960
Neometrics, Inc.
JLW
Oct 5, 2000K001606REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
Repromedix Corp.
JLW
Jun 22, 1999K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
Biocheck, Inc.
JLW
Jun 22, 1999K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003
Biocheck, Inc.
JLW
Jun 2, 1999K990658THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
Little Nell Labs, Inc.
JLW
Nov 20, 1998K983442ABBOTT ARCHITECT TSH
Abbott Laboratories
JLW
Jun 5, 1998K9813123RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Bayer Corp.
JLW
Apr 29, 1998K981060ABBOTT AXSYM 3RD GENERATION TSH ASSAY
Abbott Laboratories
JLW
Mar 24, 1998K980574AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
Alfa Biotech (Uk) , Ltd., GB
JLW
Nov 20, 1997K973276AUTODELFIA NEONATAL HTSH L KIT (B077-112)
Eg &G Wallac
JLW
Aug 29, 1997K972586AIA-PACK TSH 3RD-GEN ASSAY
Tosoh Medics, Inc.
JLW

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