K083391 is an FDA 510(k) clearance for the THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on May 21, 2009, 185 days after receiving the submission on November 17, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K083391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2008 |
| Decision Date | May 21, 2009 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| 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 |