FDA 510(k) Applications for Medical Device Product Code "MSW"
(System,Test,Thyroglobulin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220972 | Beckman Coulter, Inc | Access Thyroglobulin | 09/15/2023 |
| K240927 | Beckman Coulter, Inc | Access Thyroglobulin | 06/28/2024 |
| K241423 | Beckman Coulter, Inc | Access Thyroglobulin | 06/07/2024 |
| K002905 | BECKMAN COULTER, INC. | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER | 10/19/2000 |
| K031269 | BECKMAN COULTER, INC. | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | 05/02/2003 |
| K021057 | BRAHMS DIAGNOSTICA, LLC. | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS | 09/17/2002 |
| K982468 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY | 03/12/1999 |
| K982466 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE THYROGLOBULIN MODEL LKTY | 03/12/1999 |
| K002888 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS ADVANTAGE THYROGLOB | 10/20/2000 |
| K994140 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | 05/09/2000 |
| K221890 | Roche Diagnostics | Elecsys Tg II | 09/30/2023 |
| K242981 | Siemens Healthcare Diagnostics, Inc. | Atellica IM Thyroglobulin (Tg) | 06/20/2025 |
| K991720 | UNCHANGED | KRONUS OPTIQUANT THYROGLOBULIN KIT | 08/09/1999 |
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