The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Probnp Ii, Elecsys Probnp Ii Stat.
| Device ID | K210546 |
| 510k Number | K210546 |
| Device Name: | Elecsys ProBNP II, Elecsys ProBNP II STAT |
| Classification | Test, Natriuretic Peptide |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Jane Phillips |
| Correspondent | Jane Phillips Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2022-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336191576 | K210546 | 000 |
| 07613336191569 | K210546 | 000 |
| 07613336191521 | K210546 | 000 |