The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Elecsys Anti-tg.
| Device ID | K053426 |
| 510k Number | K053426 |
| Device Name: | ROCHE ELECSYS ANTI-TG |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Randy Johnson |
| Correspondent | Randy Johnson 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 | 2005-12-08 |
| Decision Date | 2006-02-07 |
| Summary: | summary |