BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit— 510(k) K261475
Substantially EquivalentBiofire Defense, LLC
FDA 510(k) clearance K261475 for BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit, Substantially Equivalent on 2026-07-17. Applicant: Biofire Defense, LLC. Device class: 2.
Summary
BioFire Defense's BioFire FilmArray Tropical Fever Panel Control Kit is filed under PMN, assayed external control material for microbiology nucleic acid amplification (NAT) assays. The record doesn't list the kit's contents.
Class II, 21 CFR 866.3920. Microbiology is both the classification panel and the review panel, and it was a Traditional 510(k).
BioFire Defense filed from Salt Lake City, Utah. The decision came 73 calendar days after FDA received it (May 5 to July 17, 2026).
Clearance details
- Applicant
- Biofire Defense, LLC
- Product code
- Product code PMN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
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