510(k) DEN170017
- Device
- FilmArray Respiratory Panel 2 plus (RP2plus)
- Applicant
- Biofire Diagnostics, LLC
- 510(k) number
- DEN170017
- Product code
- PZF
- Decision
- Unknown (DENG)
- Decision date
- 2017-11-24
- Date received
- 2017-03-16
- Regulation
- 866.4001
- Classification name
- Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kristen J. Kanack
- Address
- 515 Colorow Dr. Salt Lake City UT US 84108 84108
Source Documents#
510(k) summary PDF not indicated by FDA