The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Brahms Pct.
| Device ID | K192815 |
| 510k Number | K192815 |
| 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 |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-01 |
| Decision Date | 2020-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336166642 | K192815 | 000 |
| 07613336166635 | K192815 | 000 |