FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
FDA 510(k) clearance K130914 · decided 2013-06-21
Clearance details
- K-number
- K130914
- Device name
- FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
- Applicant
- Biofire Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-02
- Decision date
- 2013-06-21
- Days to decision
- 80 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 |
| FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture recall (Z-1843-2014) | BioFire Diagnostics, Inc. | 2014-06-20 |