510(k) K172337

Device

MicroScan Dried Gram Negative MIC/Combo Panels With Ceftazidime/Avibactam (0.25/4 - 64/4 Ug/mL)

Applicant

Beckman Coulter, Inc.

510(k) number

K172337

Product code

LTT  

Decision

Substantially Equivalent (SESE)

Decision date

2017-12-15

Date received

2017-08-02

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