The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Anti-tshr Immunoassay, Elecsys Precicontrol Thyroab.
| Device ID | K080092 |
| 510k Number | K080092 |
| Device Name: | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. BX 50416 Indianapolis, IN 46250 -0416 |
| Contact | Stephanie Greeman |
| Correspondent | Stephanie Greeman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. BX 50416 Indianapolis, IN 46250 -0416 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-07-28 |
| Summary: | summary |