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 | K160911 |
| 510k Number | K160911 |
| Device Name: | VIDAS B.R.A.H.M.S. PCT (PCT) |
| Classification | Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens |
| Applicant | bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Thi My Lan Dang |
| Correspondent | Thi My Lan Dang bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
| Product Code | PMT |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-06-28 |
| Summary: | summary |