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 |