The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Anti-tshr Calcheck.
| Device ID | K080643 |
| 510k Number | K080643 |
| Device Name: | ELECSYS ANTI-TSHR CALCHECK |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Stephanie Greeman |
| Correspondent | Stephanie Greeman Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-06 |
| Decision Date | 2008-08-22 |
| Summary: | summary |