510(k) K250036

Device

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)

Applicant

Beckman Coulter, Inc.

510(k) number

K250036

Product code

LTT

Decision

Substantially Equivalent (SESE)

Decision date

2025-08-15

Date received

2025-01-08

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