510(k) K123933

Device

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE

Applicant

SIEMENS HEALTHCARE DIAGNOSTICS, INC.

510(k) number

K123933

Product code

LTT  

Decision

Substantially Equivalent (SESE)

Decision date

2013-03-14

Date received

2012-12-20

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