The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Ck-mb Stat Immunoassay.
| Device ID | K140404 |
| 510k Number | K140404 |
| Device Name: | ELECSYS CK-MB STAT IMMUNOASSAY |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Kelli Turner |
| Correspondent | Kelli Turner Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-05-08 |
| Summary: | summary |