K240996 is an FDA 510(k) clearance for the Access Thyroglobulin Antibody II. This device is classified as a Immunochemical, Thyroglobulin Autoantibody (Class II - Special Controls, product code JNL).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on July 3, 2024, 83 days after receiving the submission on April 11, 2024.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K240996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2024 |
| Decision Date | July 03, 2024 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JNL — Immunochemical, Thyroglobulin Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |