The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Probnp Immunoassay.
| Device ID | K032646 |
| 510k Number | K032646 |
| Device Name: | ELECSYS PROBNP IMMUNOASSAY |
| Classification | Test, Natriuretic Peptide |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-27 |
| Decision Date | 2003-11-12 |
| Summary: | summary |