BioFire Joint Infection (JI) Panel
FDA 510(k) clearance DEN200066 · decided 2022-04-29
Clearance details
- K-number
- DEN200066
- Device name
- BioFire Joint Infection (JI) Panel
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Unknown
- Date received
- 2020-10-27
- Decision date
- 2022-04-29
- Days to decision
- 549 days
- Clearance type
- Direct
- Product code
- QSN
- Device class
- 2
- Regulation number
- 866.3988
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.