FDA 510(k) Applications for Medical Device Product Code "JLW"
(Radioimmunoassay, Thyroid-Stimulating Hormone)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K983442 | ABBOTT LABORATORIES | ABBOTT ARCHITECT TSH | 11/20/1998 |
| K981060 | ABBOTT LABORATORIES | ABBOTT AXSYM 3RD GENERATION TSH ASSAY | 04/29/1998 |
| K980574 | ALFA BIOTECH (UK) LTD. | AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 | 03/24/1998 |
| K013420 | AWARENESS TECHNOLOGY, INC. | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | 07/19/2002 |
| K981312 | BAYER CORP. | 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | 06/05/1998 |
| K023093 | BECKMAN COULTER, INC. | ACCESS HYPERSENSITIVE HTSH ASSAY | 11/25/2002 |
| K153651 | BECKMAN COULTER, INC. | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems | 08/18/2016 |
| K221225 | Beckman Coulter, Inc. | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | 11/10/2022 |
| K042281 | BECKMAN COULTER, INC. | MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY | 09/16/2004 |
| K990993 | BIOCHECK, INC. | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 | 06/22/1999 |
| K991146 | BIOCHECK, INC. | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | 06/22/1999 |
| K961566 | BIOCIRCUITS CORP. | BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS | 11/18/1996 |
| K962216 | BIOMERICA, INC. | TSH (MICROWELL) ELISA | 09/19/1996 |
| K003752 | BIOSAFE LABORATORIES, INC. | BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) | 03/23/2001 |
| K011525 | BIOSAFE LABORATORIES, INC. | SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) | 07/16/2001 |
| K170232 | BODITECH MED INC. | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | 10/13/2017 |
| K961491 | BOEHRINGER MANNHEIM CORP. | ELECSYS TSH ASSAY | 07/22/1996 |
| K060090 | DADE BEHRING, INC. | DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE | 02/27/2006 |
| K970393 | DADE CHEMISTRY SYSTEMS, INC. | THYROID STIMULATING HORMONE METHOD | 03/03/1997 |
| K130469 | DIASORIN, INC. | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 | 04/05/2013 |
| K041014 | DIASORIN, INC. | TSH-CTK-3 IRMA | 07/14/2004 |
| K973276 | EG &G WALLAC | AUTODELFIA NEONATAL HTSH L KIT (B077-112) | 11/20/1997 |
| K960195 | FRANKLIN DIAGNOSTICS, INC. | THYROCHEK ONE-STEP RAPID TSH ASSAY | 04/15/1996 |
| K171103 | Fujirebio Diagnostics, Inc. | Lumipulse G TSH-III Immunoreaction Cartridges | 07/28/2017 |
| K072458 | GOLDEN BRIDGE INTERNATIONAL, INC. | GBI TSH NEONATAL SCREENING KIT | 04/10/2008 |
| K964558 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) | 12/16/1996 |
| K990658 | LITTLE NELL LABS, INC. | THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY | 06/02/1999 |
| K110761 | MAGNABIOSCIENCES, LLC | MICT TSH | 03/09/2012 |
| K971780 | MONOBIND | THYROTROPIN(TSH) ELISA | 06/24/1997 |
| K063437 | MONOBIND, INC. | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 | 04/04/2008 |
| K131928 | NANOEN TEK USA, INC. | FREND TSH (REAGENT CARTRIDGE) | 03/14/2014 |
| K001455 | NEOMETRICS, INC. | ACCUWELL TSH, MODEL KAW-TSH-960 | 11/02/2000 |
| K961650 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT | 07/16/1996 |
| K062581 | OLYMPUS AMERICA, INC. | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | 11/29/2006 |
| K083173 | ORTHO-CLINICAL DIAGNOSTICS | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM | 12/22/2008 |
| K081543 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM | 10/23/2008 |
| K090846 | PERKINELMER, INC. | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT | 09/03/2009 |
| K011527 | PRAXSYS BIOSYSTEMS, INC. | PRAXSYS RELIA TSH TEST | 08/07/2001 |
| K052301 | Qualigen, Inc. | FASTPACK TSH IMMUNOASSAY | 01/04/2006 |
| K101390 | Qualigen, Inc. | FASTPACK TSH IMMUNOASSAY | 08/13/2010 |
| K001606 | REPROMEDIX CORP. | REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) | 10/05/2000 |
| K190773 | Roche Diagnostics | Elecsys TSH | 04/16/2019 |
| K162606 | ROCHE DIAGNOSTICS | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | 01/23/2017 |
| K962464 | SCANTIBODIES LABORATORY, INC. | SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) | 10/08/1996 |
| K162698 | SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | 07/14/2017 |
| K083844 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA CENTAUR TSH3-ULTRA METHOD | 05/08/2009 |
| K141999 | Siemens Healthcare Diagnostics Inc. | ADVIA CENTAUR TSH | 04/22/2015 |
| K222116 | Siemens Healthcare Diagnostics Inc. | Atellica« CI Analyzer, Atellica« IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica« CH Albumin BCP (AlbP) | 07/13/2023 |
| K081074 | Siemens Healthcare Diagnostics Inc. | DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 | 05/23/2008 |
| K160647 | Siemens Healthcare Diagnostics Inc. | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | 05/31/2016 |
| K150403 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ADVIA Centaur TSH3-Ultra | 05/01/2015 |
| K151792 | Siemens Healthcare Diagnostics,Inc. | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | 11/20/2015 |
| K160541 | SYSMEX AMERICA, INC. | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | 10/21/2016 |
| K961629 | TECO DIAGNOSTICS | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST | 09/11/1996 |
| K030912 | THRYOTEC | THYRO TEST | 07/25/2003 |
| K972586 | TOSOH MEDICS, INC. | AIA-PACK TSH 3RD-GEN ASSAY | 08/29/1997 |
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