510(k) K202343

Device

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

Applicant

Beckman Coulter, Inc.

510(k) number

K202343

Product code

LTT

Decision

Substantially Equivalent (SESE)

Decision date

2020-11-16

Date received

2020-08-18

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