FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
FDA 510(k) clearance K143171 · decided 2015-01-30
Clearance details
- K-number
- K143171
- Device name
- FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-11-04
- Decision date
- 2015-01-30
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PEN
- Device class
- 2
- Regulation number
- 866.3365
- 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 Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Pan recall (Z-0296-2019) | BioFire Diagnostics, LLC | 2018-10-30 |
| FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 ( recall (Z-1513-2018) | BioFire Diagnostics, LLC | 2018-04-25 |