K053426 is an FDA 510(k) clearance for the ROCHE ELECSYS ANTI-TG. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 7, 2006, 61 days after receiving the submission on December 8, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K053426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2005 |
| Decision Date | February 07, 2006 |
| Days to Decision | 61 days |
| Submission Type | Special |
| 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 |