The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche Elecsys Troponin T Stat (short Turnaround Time).
| Device ID | K051752 |
| 510k Number | K051752 |
| Device Name: | ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-29 |
| Decision Date | 2005-07-11 |
| Summary: | summary |