BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
FDA 510(k) clearance K213362 · decided 2023-03-22
Clearance details
- K-number
- K213362
- Device name
- BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
- Applicant
- Biofire Defense, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-10-12
- Decision date
- 2023-03-22
- Days to decision
- 526 days
- Clearance type
- Traditional
- Product code
- QVR
- Device class
- 2
- Regulation number
- 866.4000
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biofire Defense
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Xpert Hemorrhagic Fever (K261362) | Cepheid | 2026-08-07 |
| T2 Biothreat Panel (K231336) | T2biosystems, Inc. | 2023-09-15 |
Recalls involving this device
No recalls on record reference this clearance.