510(k) K172412

Device

BacterioScan 216Dx System

Applicant

BacterioScan, Inc.

510(k) number

K172412

Product code

QBQ  

Decision

Substantially Equivalent (SESE)

Decision date

2018-05-01

Date received

2017-08-10

Regulation

866.2560

Classification name

System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

Medical specialty

Microbiology

Review panel

Microbiology

Device class

1

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No