Product code MSW
- Device name
- System, Test, Thyroglobulin
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.6010
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 |
| K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-28 |
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-07 |
| K221890 | Elecsys Tg II | Roche Diagnostics | 2023-09-30 |
| K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023-09-15 |
| K031269 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2003-05-02 |
| K021057 | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS | Brahms Diagnostica, LLC | 2002-09-17 |
| K002888 | NICHOLS ADVANTAGE THYROGLOB | Nichols Institute Diagnostics | 2000-10-20 |
| K002905 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER | Beckman Coulter, Inc. | 2000-10-19 |
| K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | Nichols Institute Diagnostics | 2000-05-09 |
| K991720 | KRONUS OPTIQUANT THYROGLOBULIN KIT | Unchanged | 1999-08-09 |
| K982466 | IMMULITE THYROGLOBULIN MODEL LKTY | Diagnostic Products Corp. | 1999-03-12 |
| K982468 | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY | Diagnostic Products Corp. | 1999-03-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414238425 | Atellica IM Tg | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2025-09-22 |
| 00630414238418 | Atellica IM Tg | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2025-09-22 |
| 15099590754501 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023-12-01 |
| 07613336169582 | Elecsys Tg II | Roche Diagnostics GmbH | 2023-10-31 |
| 07613336203569 | Elecsys Tg II | Roche Diagnostics GmbH | 2023-10-31 |
| 00630414953199 | IMMULITE® Systems GAS CONTROL Gastrin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00816870021768 | Tg AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021775 | Tg AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023205 | Monobind AccuLite Tg CLIA Kit - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023212 | Tg AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00630414978345 | IMMULITE® Systems TG CONTROL Thyroglobulin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414972084 | IMMULITE® 2000 Systems TG Thyroglobulin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414972077 | IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414954523 | IMMULITE® Systems TG Recovery Sample Thyroglobulin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414954318 | IMMULITE® 2000 Systems TG Thyroglobulin Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414954301 | IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 15099590227173 | Access Thyroglobulin | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590227166 | Access Thyroglobulin Calibrators | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590225858 | Access Thyroglobulin Sample Diluent | Beckman Coulter, Inc. | 2016-09-09 |
| 04260157631106 | B.R.A.H.M.S Tg-pluS RIA | B.R.A.H.M.S GmbH | 2016-08-17 |