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BIOFIRE SPOTFIRE Respiratory (R) Panel

Biofire Diagnostics · Class II · Cleared Feb 3, 2023

K-numberK213954
Device nameBIOFIRE SPOTFIRE Respiratory (R) Panel
ApplicantBiofire Diagnostics
Product codeQOF
Device classClass II
Decision dateFeb 3, 2023
DecisionSubstantially Equivalent
Regulation866.3981
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Source

View the full FDA submission: accessdata.fda.gov

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