K020348 is an FDA 510(k) clearance for the ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on May 2, 2002, 87 days after receiving the submission on February 4, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K020348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2002 |
| Decision Date | May 02, 2002 |
| Days to Decision | 87 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 |