The following data is part of a premarket notification filed by Olympus Life & Material Science Europa Gmbh (irish with the FDA for Olympus Ck-mb Reagent.
| Device ID | K070835 |
| 510k Number | K070835 |
| Device Name: | OLYMPUS CK-MB REAGENT |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH LISMEEHAN O'callaghans Mills, Co. Clare, IE |
| Contact | Stephanie G Schwartz |
| Correspondent | Stephanie G Schwartz OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH LISMEEHAN O'callaghans Mills, Co. Clare, IE |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-27 |
| Decision Date | 2007-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590011468 | K070835 | 000 |