The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Cobas Elecsys Anti-tpo.
| Device ID | K051890 |
| 510k Number | K051890 |
| Device Name: | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-12 |
| Decision Date | 2005-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630939626 | K051890 | 000 |
| 04015630929702 | K051890 | 000 |