BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
FDA 510(k) clearance K220870 · decided 2022-10-20
Clearance details
- K-number
- K220870
- Device name
- BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
- Applicant
- Biofire Defense, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-03-25
- Decision date
- 2022-10-20
- Days to decision
- 209 days
- Clearance type
- Traditional
- 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 FILMARRAY Tropical Fever Panel (K243463) | Biofire Diagnostics, LLC (Biomerieux) | 2024-12-05 |
| FilmArray Global Fever Panel (DEN200043) | Biofire Defense, LLC | 2020-11-20 |
Recalls involving this device
No recalls on record reference this clearance.