The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Respiratory Panel (rp) For Use With Filmarray Torch.
| Device ID | K160068 |
| 510k Number | K160068 |
| Device Name: | FilmArray Respiratory Panel (RP) For Use With FilmArray Torch |
| Classification | Respiratory Virus Panel Nucleic Acid 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 | OCC |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOU |
| Subsequent Product Code | OTG |
| Subsequent Product Code | OZX |
| Subsequent Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-13 |
| Decision Date | 2016-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020284 | K160068 | 000 |
| 00815381020277 | K160068 | 000 |
| 00815381020260 | K160068 | 000 |
| 00815381020253 | K160068 | 000 |
| 00815381029089 | K160068 | 000 |
| 00815381029072 | K160068 | 000 |