The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Brahms Pct.
| Device ID | K173927 |
| 510k Number | K173927 |
| Device Name: | Elecsys BRAHMS PCT |
| Classification | Procalcitonin Assay |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Wes Gerbig |
| Correspondent | Wes Gerbig Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | PRI |
| Subsequent Product Code | NTM |
| Subsequent Product Code | PMT |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-07-06 |
| Summary: | summary |