The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Blood Culture Identification (bcid) Panel.
| Device ID | K181493 |
| 510k Number | K181493 |
| Device Name: | FilmArray Blood Culture Identification (BCID) Panel |
| Classification | Gram-negative Bacteria And Associated Resistance Markers |
| Applicant | BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Contact | Kristen J. Kanack |
| Correspondent | Kristen J. Kanack BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Product Code | PEN |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-06 |
| Decision Date | 2018-07-05 |
| Summary: | summary |