The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Troponin I And Troponin I Stat Test Systems.
| Device ID | K082699 |
| 510k Number | K082699 |
| Device Name: | ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Jane Phillips |
| Correspondent | Jane Phillips Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | MMI |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2009-08-19 |
| Summary: | summary |