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)
Top companies in JLW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Thyroid TSH Test Open, Classified |
JLW | None listed |
| Oct 21, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Part Number C11137 Open, Classified |
JLW | K221225 |
| Jun 6, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20 Open, Classified |
JLW | K221225 |
| Jun 5, 2025 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 Open, Classified |
JLW | K221225 |
| Oct 16, 2024 | Beckman Coulter, Inc. The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human Open, Classified |
JLW | K221225 |
| Oct 8, 2024 | Qualigen Inc FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer Open, Classified |
JLW | K052301 |
| Apr 13, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens
Siemens Material Number (SMN): 11066000 Open, Classified |
JLW | K151792 |
| Apr 13, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.
Siemens Material Number (SMN): 11066001 Open, Classified |
JLW | K151792 |
| May 13, 2021 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens
SMN 11066000 Open, Classified |
JLW | K151792 |
| May 13, 2021 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens
SMN 11066001 Open, Classified |
JLW | K151792 |
| Oct 26, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens.
Siemens Material Number (SMN): 11066000 Terminated |
JLW | K151792 |
| Oct 26, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 Terminated |
JLW | K151792 |
| Aug 13, 2019 | Roche Diagnostics Operations, Inc. AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids)
Catalog Number: 5694 Terminated |
JLW | K162606 |
| Mar 7, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1600 Analyzer, Material Number 11066000 Terminated |
JLW | K151792 |
| Mar 7, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer, Material Number 11066001 Terminated |
JLW | K151792 |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i TSH Reagent Kit, List Number 07P4830 Terminated |
JLW | K983442 |
| Aug 15, 2018 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System- (Refurbished).
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,
Catalog Number: 680291 Terminated |
JLW | K081543 |
| Aug 15, 2018 | Ortho-Clinical Diagnostics VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,
Catalog Number: 6802413 Terminated |
JLW | K081543 |
| Jul 12, 2018 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products - TSH Reagent Pack
(10758750000227) 1912997 Open, Classified |
JLW | K081543 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge Terminated |
JLW | K140859 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge Terminated |
JLW | K140842 |
| Apr 10, 2018 | Clinical Diagnostic Systems VITROS Immunodiagnostic Products TSH Reagent Pack Terminated |
JLW | K083173 |
| Mar 5, 2018 | Tosoh Bioscience Inc AIA-PACK TSH 3rd Generation; Part Number: 020294
Assay, Thyroid Terminated |
JLW | K972586 |
| Dec 18, 2017 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests) Open, Classified |
JLW | K150403 |
| May 5, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge Terminated |
JLW | K140859 |
| Jul 28, 2016 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ U Terminated |
JLW | K083173 |
| May 26, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979).
Terminated |
JLW | K141999 |
| Apr 28, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur XPT Immunoassay System Terminated |
JLW | K141999 |
| Jun 4, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Terminated |
JLW | K140859 |
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TSH3 Ultra 2500 tests
Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944.
Intended for the invitro diagnostic use in quantitative determination of various assays Terminated |
JLW | K110586 |
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test
Catalog Number: 06491080; Siemens Material Number: 10282379.
Intended for the invitro diagnostic use in quantitative determination of various a Terminated |
JLW | K083844 |
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test
Catalog Number: 06491072; Siemens Material Number: 10282378.
Intended for the invitro diagnostic use in quantitative determination of various as Terminated |
JLW | K083844 |
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | K933212 |
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | K940006 |
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc Dimension Vista System TSH Flex Reagent Cartridge (REF K6412).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | K060090 |
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | K081074 |
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc Dimension TSH Flex Reagent Cartridge (REF RF412).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | K081074 |
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyr Terminated |
JLW | K083844 |
| Jan 7, 2013 | Siemens Healthcare Diagnostics Immunoradiometric assay.
Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitr Terminated |
JLW | K872305 |
| Jan 7, 2013 | Siemens Healthcare Diagnostics Immunoradiometric assay. Terminated |
JLW | K872305 |
| Jan 7, 2013 | Siemens Healthcare Diagnostics Immunoradiometric assay.
Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitr Terminated |
JLW | K872305 |
| Aug 1, 2012 | Perkinelmer Perkin Elmer Genetic Screening Processor (GSP)
Product Code: 2021-0010
Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescen Terminated |
JLW | K090846 |
| Jan 11, 2012 | PerkinElmer LAS, Inc The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates Terminated |
JLW | K090846 |
| Nov 24, 2010 | Siemens Healthcare Diagnostics, Inc. The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE. Terminated |
JLW | K081074 |
| Mar 22, 2007 | ThyroTec Inc Thyrotest TSH POC Rapid membrane test. In vitro diagnostic. Terminated |
JLW | K030912 |
| Apr 28, 2005 | Nichols Institute Diagnostics Nichols Advantage TSH - Third Generation Terminated |
JLW | None listed |
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