The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Tsh Assay, Cobas E 801 Immunoassay Analyzer.
| Device ID | K162606 |
| 510k Number | K162606 |
| Device Name: | Elecsys TSH Assay, Cobas E 801 Immunoassay Analyzer |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Angelo Pereira |
| Correspondent | Angelo Pereira 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 | 2016-09-19 |
| Decision Date | 2017-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630946198 | K162606 | 000 |