The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray 2.0 System.
| Device ID | K143178 |
| 510k Number | K143178 |
| Device Name: | FilmArray 2.0 System |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| 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 | NSU |
| CFR Regulation Number | 862.2570 [🔎] |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020048 | K143178 | 000 |
| 00815381020031 | K143178 | 000 |
| 00851458005143 | K143178 | 000 |
| 00851458005129 | K143178 | 000 |
| 00851458005051 | K143178 | 000 |
| 00815381029058 | K143178 | 000 |
| 00851458005297 | K143178 | 000 |