The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To Elecsys Ck-mb Stat, Elecsys Ck-mb.
| Device ID | K022654 |
| 510k Number | K022654 |
| Device Name: | MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-09 |
| Decision Date | 2002-08-29 |
| Summary: | summary |