The following data is part of a premarket notification filed by Biofire Diagnostics, Llc. with the FDA for Filmarray Blood Culture Identification (bcid) Panel For Use With The Filmarray 2.0.
| Device ID | K143171 |
| 510k Number | K143171 |
| Device Name: | FilmArray Blood Culture Identification (BCID) Panel For Use With The FilmArray 2.0 |
| Classification | Gram-negative Bacteria And Associated Resistance Markers |
| Applicant | Biofire Diagnostics, LLC. 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Kristen Kanack, Phd |
| Correspondent | Kristen Kanack, Phd Biofire Diagnostics, LLC. 390 Wakara Way Salt Lake City, UT 84108 |
| Product Code | PEN |
| Subsequent Product Code | OOI |
| Subsequent Product Code | PAM |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-04 |
| Decision Date | 2015-01-30 |
| Summary: | summary |