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 |