510(k) K083262

Device

MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)

Applicant

SIEMENS HEALTHCARE DIAGNOSTICS

510(k) number

K083262

Product code

LTT  

Decision

Substantially Equivalent (SESE)

Decision date

2009-02-18

Date received

2008-11-05

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