510(k) K150039

Device

MicroScan Dried Gram Positive MIC/Combo Panels With Vancomycin (0.25-64 Mcg/mL)

Applicant

Siemens Healthcare Diagnostics Inc.

510(k) number

K150039

Product code

LTT  

Decision

Substantially Equivalent (SESE)

Decision date

2015-07-02

Date received

2015-01-09

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