Access Thyroglobulin
FDA 510(k) K240927 · Beckman Coulter, Inc.
510(k) numberK240927
Submission
- Device name
- Access Thyroglobulin
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- April 4, 2024
- Decision date
- June 28, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSW – System, Test, Thyroglobulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code MSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/20/2025SE |
| K241423 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 06/07/2024SE |
| K221890 | Elecsys Tg IIMSW · Traditional | Roche Diagnostics | 09/30/2023SE |
| K220972 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 09/15/2023SE |
| K031269 | Access Thyroglobulin Reagents on the Access Immunoassay SystemsMSW · Special | Beckman Coulter, Inc. | 05/02/2003SE |
| K021057 | Brahms Diagnostica Dynotest Tg-PlusMSW · Traditional | Brahms Diagnostica, LLC | 09/17/2002SE |
| K002888 | Nichols Advantage ThyroglobMSW · Traditional | Nichols Institute Diagnostics | 10/20/2000SE |
| K002905 | Access Thyroglobulin Reagents on the Access AnalyzerMSW · Traditional | Beckman Coulter, Inc. | 10/19/2000SE |
| K994140 | Nichols Chemiluminescence Thyroglobulin, Model 60-4240MSW · Traditional | Nichols Institute Diagnostics | 05/09/2000SE |
| K991720 | Kronus Optiquant Thyroglobulin KitMSW · Traditional | Unchanged | 08/09/1999SE |
More from Unchanged
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access Thyroglobulin cleared by the FDA?
Access Thyroglobulin (K240927) received a 510(k) decision of Substantially Equivalent on June 28, 2024, 85 days after the submission was received.
What is the product code of K240927?
The FDA product code is MSW – System, Test, Thyroglobulin, a Class II (moderate risk) device regulated under 21 CFR 866.6010.