FDA.report

510(k) K242367

Device
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Applicant
Biofire Diagnostics, LLC
510(k) number
K242367
Product code
PCH
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-07
Date received
2024-08-09
Regulation
866.3990
Classification name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Karli Plenert
Address
515 Colorow Dr. Salt Lake City UT US 84108 84108

FDA Registration Numbers

Source Documents

510(k) summary PDF

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