The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecys Brahms Pct, Elecys Brahms Pct Calcheck 5.
| Device ID | K160729 |
| 510k Number | K160729 |
| Device Name: | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 |
| Classification | Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Adam Clark |
| Correspondent | Adam Clark Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | PMT |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-16 |
| Decision Date | 2016-06-13 |
| Summary: | summary |