The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Respiratory Panel Ez (rp Ez).
| Device ID | K152579 |
| 510k Number | K152579 |
| Device Name: | FilmArray Respiratory Panel EZ (RP EZ) |
| 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 | 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 | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-10 |
| Decision Date | 2016-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020147 | K152579 | 000 |