510(k) K183127

Device

MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem/Vaborbactam (0.03/8-64/8ug/mL)

Applicant

Beckman Coulter, Inc.

510(k) number

K183127

Product code

LTT  

Decision

Substantially Equivalent (SESE)

Decision date

2019-02-12

Date received

2018-11-13

Regulation

866.1640

Classification name

Panels, Test, Susceptibility, Antimicrobial

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No