510(k) K131729

Device

JBAIDS PLAGUE DETECTION KIT

Applicant

BIOFIRE DIAGNOSTICS, INC.

510(k) number

K131729

Product code

OIH  

Decision

Substantially Equivalent (SESE)

Decision date

2013-07-31

Date received

2013-06-12

Regulation

510(k) Premarket Notification

Classification name

Yersinia Spp. Reagents

Medical specialty

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Review panel

Microbiology

Device class

U

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No