BioFire Joint Infection (JI) Panel— 510(k) DEN200066
UnknownBiofire Diagnostics, LLC
FDA 510(k) clearance DEN200066 for BioFire Joint Infection (JI) Panel, Unknown on 2022-04-29. Applicant: Biofire Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Code QSN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3988
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Salt Lake City, UT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.