Panels › Immunology › Product code MSW · Class 2
System, Test, Thyroglobulin
Regulation 866.6010
0510(k)s in 12 months (13 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in MSW
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 5 | 6 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 4 |
| Diagnostic Products Corp. | 2 | 0 |
| Nichols Institute Diagnostics | 2 | 0 |
| Brahms Diagnostica, LLC | 1 | 0 |
| Roche Diagnostics | 1 | 0 |
| Unchanged | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | Beckman Coulter, Inc. Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 Open, Classified |
MSW | K031269 |
| Oct 11, 2023 | Beckman Coulter, Inc. Access Thyroglobulin Calibrators Open, Classified |
MSW | K031269 |
| Jan 11, 2023 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in Open, Classified |
MSW | K982468 |
| Jan 11, 2023 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum o Open, Classified |
MSW | K982468 |
| Jun 2, 2020 | Beckman Coulter Inc. Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including:
Access 2, UniCel DxI 600, UniCel DxI Terminated |
MSW | K002905 K031269 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi TG Terminated |
MSW | K982468 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE /IMMULITE 1000 TG Terminated |
MSW | K982466 |
| May 9, 2017 | Beckman Coulter Inc. Access Thyroglobulin, A34085G, Catalog No. 33860 Terminated |
MSW | K002905 K031269 |
| Sep 3, 2015 | Beckman Coulter Inc. Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. Terminated |
MSW | K002905 K031269 |
| May 19, 2011 | Beckman Coulter Inc. Access Immunoassay Systems Thyroglobulin,
Part Number: 33860
This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid glan Terminated |
MSW | K002905 K031269 |
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