K213517 is an FDA 510(k) clearance for the Access Thyroglobulin Antibody II. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 26, 2023, 692 days after receiving the submission on November 3, 2021.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K213517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2021 |
| Decision Date | September 26, 2023 |
| Days to Decision | 692 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JZO — System, Test, Thyroid Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |