K220972 is an FDA 510(k) clearance for the Access Thyroglobulin. This device is classified as a System, Test, Thyroglobulin (Class II - Special Controls, product code MSW).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 15, 2023, 529 days after receiving the submission on April 4, 2022.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K220972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | September 15, 2023 |
| Days to Decision | 529 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MSW — System, Test, Thyroglobulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |