510(k) K162740

Device

MicroScan Dried Gram-Negative MIC/Combo Panels With Imipenem (0.25 - 8 Ug/mL)

Applicant

BECKMAN COULTER, INC.

510(k) number

K162740

Product code

LTT  

Decision

Substantially Equivalent (SESE)

Decision date

2017-03-21

Date received

2016-09-30

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