The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Troponin T Stat Test.
| Device ID | K040733 |
| 510k Number | K040733 |
| Device Name: | ELECSYS TROPONIN T STAT TEST |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-22 |
| Decision Date | 2004-05-17 |
| Summary: | summary |