510(k) DEN160048
- Device
- FilmArray NGDS Warrior Panel
- Applicant
- Biofire Defense, LLC
- 510(k) number
- DEN160048
- Product code
- PRD
- Decision
- Unknown (DENG)
- Decision date
- 2017-02-14
- Date received
- 2016-10-17
- Review panel
- Immunology
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Cynthia Phillips
- Address
- 79 W 4500 S Suite 14 Salt Lake City UT US 84107 84107
FDA Registration Numbers#
- 3010770794
Source Documents#
510(k) summary PDF not indicated by FDA