Atlas FDA

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

FDA 510(k) clearance K243544 · decided 2025-08-14

Clearance details

K-number
K243544
Device name
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
Applicant
Biofire Diagnostics, LLC
Decision
Substantially Equivalent
Date received
2024-11-15
Decision date
2025-08-14
Days to decision
272 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

No recalls on record reference this clearance.