The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Tsh.
| Device ID | K190773 |
| 510k Number | K190773 |
| Device Name: | Elecsys TSH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Edie Eads |
| Correspondent | Edie Eads Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-26 |
| Decision Date | 2019-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336157633 | K190773 | 000 |
| 07613336157626 | K190773 | 000 |