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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2025 | K242981 | Atellica IM Thyroglobulin (Tg) Siemens Healthcare Diagnostics, Inc. | MSW |
| Jun 28, 2024 | K240927 | Access Thyroglobulin Beckman Coulter, Inc. | MSW |
| Jun 7, 2024 | K241423 | Access Thyroglobulin Beckman Coulter, Inc. | MSW |
| Sep 30, 2023 | K221890 | Elecsys Tg II Roche Diagnostics | MSW |
| Sep 15, 2023 | K220972 | Access Thyroglobulin Beckman Coulter, Inc. | MSW |
| May 2, 2003 | K031269 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. | MSW |
| Sep 17, 2002 | K021057 | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS Brahms Diagnostica, LLC | MSW |
| Oct 20, 2000 | K002888 | NICHOLS ADVANTAGE THYROGLOB Nichols Institute Diagnostics | MSW |
| Oct 19, 2000 | K002905 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER Beckman Coulter, Inc. | MSW |
| May 9, 2000 | K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 Nichols Institute Diagnostics | MSW |
| Aug 9, 1999 | K991720 | KRONUS OPTIQUANT THYROGLOBULIN KIT Unchanged | MSW |
| Mar 12, 1999 | K982468 | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY Diagnostic Products Corp. | MSW |
| Mar 12, 1999 | K982466 | IMMULITE THYROGLOBULIN MODEL LKTY Diagnostic Products Corp. | MSW |
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