The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Anti-tshr.
| Device ID | K193313 |
| 510k Number | K193313 |
| Device Name: | Elecsys Anti-TSHR |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 |
| Contact | Reanna Toney |
| Correspondent | Reanna Toney Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-29 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336160329 | K193313 | 000 |
| 07613336160305 | K193313 | 000 |