Device Listing 1675811793

Listing Summary#

Listing key
1675811793
Premarket submission
K243759
Device
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
Applicant
Biofire Diagnostics, LLC
Product code
PEN
Decision date
2024-12-20