K112933 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN ANITBODY. 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 December 27, 2011, 85 days after receiving the submission on October 3, 2011.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K112933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2011 |
| Decision Date | December 27, 2011 |
| Days to Decision | 85 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 |