MSW — System, Test, Thyroglobulin Class II
FDA product code MSW covers "System, Test, Thyroglobulin", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MSW
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242981 | siemens healthcare diagnostics | Atellica IM Thyroglobulin (Tg) | June 20, 2025 |
| K240927 | beckman coulter | Access Thyroglobulin | June 28, 2024 |
| K241423 | beckman coulter | Access Thyroglobulin | June 7, 2024 |
| K221890 | roche diagnostics | Elecsys Tg II | September 30, 2023 |
| K220972 | beckman coulter | Access Thyroglobulin | September 15, 2023 |
| K031269 | beckman coulter | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | May 2, 2003 |
| K021057 | brahms diagnostica | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS | September 17, 2002 |
| K002888 | nichols institute diagnostics | NICHOLS ADVANTAGE THYROGLOB | October 20, 2000 |
| K002905 | beckman coulter | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER | October 19, 2000 |
| K994140 | nichols institute diagnostics | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | May 9, 2000 |
| K991720 | unchanged | KRONUS OPTIQUANT THYROGLOBULIN KIT | August 9, 1999 |
| K982468 | diagnostic products | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY | March 12, 1999 |
| K982466 | diagnostic products | IMMULITE THYROGLOBULIN MODEL LKTY | March 12, 1999 |