510(k) K180966
- Device
- FilmArray Pneumonia Panel
- Applicant
- BioFire Diagnostics, LLC
- 510(k) number
- K180966
- Product code
- QBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-09
- Date received
- 2018-04-13
- Regulation
- 866.3985
- Classification name
- Lower Respiratory Microbial Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kristen J. Kanack
- Address
- 515 Colorow Dr. Salt Lake City UT US 84108 84108
FDA Registration Numbers#
- 3002773840
Source Documents#
Other 510(k) Records For Product Code QBH #
Legacy Summary#
summary
FDA Review#
Decision Summary