VIDAS B.R.A.H.M.S. PCT (PCT)— 510(k) K162827

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code PRI

Device class

Class 2

Regulation

21 CFR 866.3215

Advisory panel

Microbiology

Date received

2016-10-07

Decision date

2017-02-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

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