The following data is part of a premarket notification filed by Idaho Technology, Inc. with the FDA for Filmarray Rp Panel.
| Device ID | K110764 |
| 510k Number | K110764 |
| Device Name: | FILMARRAY RP PANEL |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Beth Lingenfelter |
| Correspondent | Beth Lingenfelter IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Product Code | OCC |
| Subsequent Product Code | NXD |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OOU |
| Subsequent Product Code | OTG |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-18 |
| Decision Date | 2011-04-27 |
| Summary: | summary |