The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Creatine Kinase-mb.
| Device ID | K162526 |
| 510k Number | K162526 |
| Device Name: | Creatine Kinase-MB |
| Classification | U.v. Method, Cpk Isoenzymes |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Noel B. Mencias |
| Correspondent | Noel B. Mencias ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-09 |
| Decision Date | 2017-05-26 |
| Summary: | summary |