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BIOFIRE SPOTFIRE Respiratory (R) Panel

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213954
510(k) Type
Dual Track
Applicant
BioFire Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/3/2023
Days to Decision
413 days
Submission Type
Summary

BIOFIRE SPOTFIRE Respiratory (R) Panel

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213954
510(k) Type
Dual Track
Applicant
BioFire Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/3/2023
Days to Decision
413 days
Submission Type
Summary