510(k) K243463

Device

BIOFIRE FILMARRAY Tropical Fever Panel

Applicant

Biofire Diagnostics, LLC (Biomerieux)

510(k) number

K243463

Product code

QMV

Decision

Substantially Equivalent (SESE)

Decision date

2024-12-05

Date received

2024-11-08

Regulation

866.3966

Classification name

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Special

Statement or summary

Summary

Third party reviewed

No