The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Probnp Ii, Precicontrol Cardiac Ii, Probnp Ii Calset.
| Device ID | K072437 |
| 510k Number | K072437 |
| Device Name: | ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET |
| Classification | Test, Natriuretic Peptide |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Kay Taylor |
| Correspondent | Kay Taylor Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | NBC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-23 |
| Decision Date | 2008-02-05 |
| Summary: | summary |