The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Filmarray Respiratory Panel (rp).
| Device ID | K123620 |
| 510k Number | K123620 |
| Device Name: | FILMARRAY RESPIRATORY PANEL (RP) |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Beth Lingenfelter |
| Correspondent | Beth Lingenfelter BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Product Code | OCC |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OOU |
| Subsequent Product Code | OQW |
| 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 | 2012-11-23 |
| Decision Date | 2013-02-11 |
| Summary: | summary |