510(k) K243804

Device

MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)

Applicant

Beckman Coulter, Inc.

510(k) number

K243804

Product code

LTT

Decision

Substantially Equivalent (SESE)

Decision date

2025-08-20

Date received

2024-12-11

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

N