The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Probnp Ii Stat Immunoassay And Elecsys Probnp Ii Calset, Models 05390109-160, 04842472-190.
| Device ID | K092649 |
| 510k Number | K092649 |
| Device Name: | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 |
| Classification | Test, Natriuretic Peptide |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Jane E Phillips |
| Correspondent | Jane E Phillips ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-28 |
| Decision Date | 2010-02-04 |
| Summary: | summary |