The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Gastrointestinal Panel (gi) For Use With Filmarray Torch.
| Device ID | K160459 |
| 510k Number | K160459 |
| Device Name: | FilmArray Gastrointestinal Panel (GI) For Use With FilmArray Torch |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | BIOFIRE DIAGNOSTICS, LLC 390 WAKARA WAY Salt Lake City, UT 84108 |
| Contact | Kristen J. Kanack |
| Correspondent | Kristen J. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-04-01 |
| Summary: | summary |