510(k) DEN200066
- Device
- BioFire Joint Infection (JI) Panel
- Applicant
- Biofire Diagnostics, LLC
- 510(k) number
- DEN200066
- Product code
- QSN
- Decision
- Unknown (DENG)
- Decision date
- 2022-04-29
- Date received
- 2020-10-27
- Regulation
- 866.3988
- Classification name
- Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kevin Bourzac
- Address
- 515 Colorow Dr. Salt Lake City UT US 84108 84108
FDA Registration Numbers#
- 3002773840
Source Documents#
510(k) summary PDF not indicated by FDA