510(k) K172912

Device

MicroScan Dried Gram-Negative MIC/Combo Panels With Ciprofloxacin-S (0.004 – 8 µg/mL)

Applicant

Beckman Coulter Inc.

510(k) number

K172912

Product code

LTT  

Decision

Substantially Equivalent (SESE)

Decision date

2017-12-07

Date received

2017-09-25

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