K984163 is an FDA 510(k) clearance for the ANTI-TPO EIA DIAGNOSTIC TEST KIT. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 2, 1999, 74 days after receiving the submission on November 20, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K984163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1998 |
| Decision Date | February 02, 1999 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | JZO — System, Test, Thyroid Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |