Atlas FDA

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

FDA 510(k) clearance K232954 · decided 2024-03-26

Clearance details

K-number
K232954
Device name
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
Applicant
Biofire Diagnostics, LLC
Decision
Substantially Equivalent
Date received
2023-09-21
Decision date
2024-03-26
Days to decision
187 days
Clearance type
Dual Track
Product code
QOF
Device class
2
Regulation number
866.3981
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Salt Lake City, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 recall (Z-2081-2026)BioFire Diagnostics, LLC2026-05-06