K062516 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS). 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 October 5, 2006, 38 days after receiving the submission on August 28, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K062516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2006 |
| Decision Date | October 05, 2006 |
| Days to Decision | 38 days |
| Submission Type | Special |
| 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 |