The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Thyroid Stimulating Immunoglobulin Reporter Assay.
| Device ID | K083391 |
| 510k Number | K083391 |
| Device Name: | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Contact | Gail R Goodrum |
| Correspondent | Gail R Goodrum DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-17 |
| Decision Date | 2009-05-21 |
| Summary: | summary |