The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Myoglobin Stat, And Elecsys Myoglobin.
| Device ID | K083260 |
| 510k Number | K083260 |
| Device Name: | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50457 Indianapolis, IN 46250 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50457 Indianapolis, IN 46250 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-05 |
| Decision Date | 2009-10-16 |
| Summary: | summary |