BIOFIRE FILMARRAY Tropical Fever Panel
FDA 510(k) clearance K243463 · decided 2024-12-05
Clearance details
- K-number
- K243463
- Device name
- BIOFIRE FILMARRAY Tropical Fever Panel
- Applicant
- Biofire Diagnostics, LLC (Biomerieux)
- Decision
- Substantially Equivalent
- Date received
- 2024-11-08
- Decision date
- 2024-12-05
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- QMV
- Device class
- 2
- Regulation number
- 866.3966
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (K220870) | Biofire Defense, LLC | 2022-10-20 |
| FilmArray Global Fever Panel (DEN200043) | Biofire Defense, LLC | 2020-11-20 |
Recalls involving this device
No recalls on record reference this clearance.