510(k) K250084

Device

MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)

Applicant

Beckman Coulter, Inc.

510(k) number

K250084

Product code

LTT

Decision

Substantially Equivalent (SESE)

Decision date

2025-07-18

Date received

2025-01-13

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

N