The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Respiratory Panel 2 (rp2).
| Device ID | K170604 |
| 510k Number | K170604 |
| Device Name: | FilmArray Respiratory Panel 2 (RP2) |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Contact | Kristen J. Kanack |
| Correspondent | Kristen J. Kanack BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Product Code | OCC |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOU |
| Subsequent Product Code | OTG |
| Subsequent Product Code | OZX |
| Subsequent Product Code | OZY |
| Subsequent Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020161 | K170604 | 000 |
| 00815381020154 | K170604 | 000 |