FilmArray Pneumonia Panel
FDA 510(k) clearance K180966 · decided 2018-11-09
Clearance details
- K-number
- K180966
- Device name
- FilmArray Pneumonia Panel
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-04-13
- Decision date
- 2018-11-09
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- QDP
- Device class
- 2
- Regulation number
- 866.3985
- 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 |
|---|---|---|
| FilmArray Pneumonia Panel (K212727) | Biofire Diagnostics, LLC | 2021-09-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit recall (Z-0994-2024) | BioFire Diagnostics, LLC | 2024-02-06 |
| FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IV recall (Z-2440-2023) | BioFire Diagnostics, LLC | 2023-08-21 |