The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Gastrointestinal (gi) Panel For Use With The Filmarray 2.0.
| Device ID | K143005 |
| 510k Number | K143005 |
| Device Name: | FilmArray Gastrointestinal (GI) Panel For Use With The FilmArray 2.0 |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Kristen Kanack |
| Correspondent | Kristen Kanack BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City, UT 84108 |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-20 |
| Decision Date | 2015-02-19 |
| Summary: | summary |