510(k) K201423

Device

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)

Applicant

Beckman Coulter, Inc.

510(k) number

K201423

Product code

LTT

Decision

Substantially Equivalent (SESE)

Decision date

2020-06-29

Date received

2020-05-29

Regulation

866.1640

Classification name

Panels, Test, Susceptibility, Antimicrobial

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Special

Statement or summary

Summary

Third party reviewed

No