The following data is part of a premarket notification filed by Biofire Diagnostics with the FDA for Filmarray Gastrointestinal (gi) Panel.
| Device ID | K140407 |
| 510k Number | K140407 |
| Device Name: | FILMARRAY GASTROINTESTINAL (GI) PANEL |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Biofire Diagnostics 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Beth Lingenfelter |
| Correspondent | Beth Lingenfelter Biofire Diagnostics 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 | 2014-02-18 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020116 | K140407 | 000 |
| 00815381020109 | K140407 | 000 |