510(k) K181324
- Device
- FilmArray Pneumonia Panel Plus
- Applicant
- BioFire Diagnostics, LLC
- 510(k) number
- K181324
- Product code
- QDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-15
- Date received
- 2018-05-18
- Regulation
- 866.4001
- Classification name
- Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System
- Medical specialty
- Pathology
- 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 QDS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | Biofire Diagnostics, LLC (Biomerieux) | 2024-11-06 |
| K222601 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | 2022-10-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary