FDA Product Code
FDA Product Code MSW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 | Traditional | PDF ↗ |
| K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-28 | Traditional | PDF ↗ |
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-07 | Traditional | PDF ↗ |
| K221890 | Elecsys Tg II | Roche Diagnostics | 2023-09-30 | Traditional | PDF ↗ |
| K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023-09-15 | Traditional | PDF ↗ |
| K031269 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2003-05-02 | Special | PDF ↗ |
| K021057 | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS | Brahms Diagnostica, LLC | 2002-09-17 | Traditional | PDF ↗ |
| K002888 | NICHOLS ADVANTAGE THYROGLOB | Nichols Institute Diagnostics | 2000-10-20 | Traditional | PDF ↗ |
| K002905 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER | Beckman Coulter, Inc. | 2000-10-19 | Traditional | PDF ↗ |
| K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | Nichols Institute Diagnostics | 2000-05-09 | Traditional | PDF ↗ |
| K991720 | KRONUS OPTIQUANT THYROGLOBULIN KIT | Unchanged | 1999-08-09 | Traditional | PDF ↗ |
| K982468 | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY | Diagnostic Products Corp. | 1999-03-12 | Traditional | PDF ↗ |
| K982466 | IMMULITE THYROGLOBULIN MODEL LKTY | Diagnostic Products Corp. | 1999-03-12 | Traditional | PDF ↗ |
Product code MSW · Class II · Immunology. Data: openFDA.