The following data is part of a premarket notification filed by Biomerieux, Inc with the FDA for Vidas B.r.a.h.m.s. Pct (pct).
Device ID | K162827 |
510k Number | K162827 |
Device Name: | VIDAS B.R.A.H.M.S. PCT (PCT) |
Classification | Procalcitonin Assay |
Applicant | bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
Contact | John Albright |
Correspondent | John Albright bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
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 | 2016-10-07 |
Decision Date | 2017-02-23 |
Summary: | summary |