The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Ck-mb Stat Immunoassay, Elecsys Ck-mb Immunoassay.
| Device ID | K132571 |
| 510k Number | K132571 |
| Device Name: | ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Kelli Turner |
| Correspondent | Kelli Turner Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-15 |
| Decision Date | 2013-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630934621 | K132571 | 000 |