FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
FDA 510(k) clearance K160459 · decided 2016-04-01
Clearance details
- K-number
- K160459
- Device name
- FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-02-19
- Decision date
- 2016-04-01
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- PCH
- Device class
- 2
- Regulation number
- 866.3990
- 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
| Record | Firm | Date |
|---|---|---|
| FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Modu recall (Z-2588-2023) | BioFire Diagnostics, LLC | 2024-09-30 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILM recall (Z-2514-2024) | BioFire Diagnostics, LLC | 2024-08-06 |
| FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test ki recall (Z-1140-2024) | BioFire Diagnostics, LLC | 2024-02-15 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-ba recall (Z-0703-2024) | BioFire Diagnostics, LLC | 2024-01-10 |
| In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 recall (Z-1253-2023) | BioFire Diagnostics, LLC | 2023-03-15 |