Device Listing 1352208301
Listing Summary#
- Listing key
- 1352208301
- Premarket submission
- K160462
- Device
- FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
- Applicant
- Biofire Diagnostics, LLC
- Product code
- PLO
- Decision date
- 2016-03-17