K011082 is an FDA 510(k) clearance for the TPO IGG ANTIBODY EIA TEST. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on June 6, 2001, 57 days after receiving the submission on April 10, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K011082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2001 |
| Decision Date | June 06, 2001 |
| Days to Decision | 57 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 |