BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini— 510(k) K230719
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K230719 for BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini, Substantially Equivalent on 2023-04-13. Applicant: Biofire Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Code QOF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.