510(k) K033940

Device

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)

Applicant

DADE BEHRING, INC.

510(k) number

K033940

Product code

LTT  

Decision

Substantially Equivalent (SESE)

Decision date

2004-02-25

Date received

2003-12-19

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