510(k) K052485

Device

SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF

Applicant

MIDI, INC.

510(k) number

K052485

Product code

NWZ  

Decision

Substantially Equivalent (SESE)

Decision date

2006-01-17

Date received

2005-09-09

Regulation

866.3045

Classification name

Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No