FDA.reportPublic FDA data

Device Listing 1398877114

Listing Summary#

Listing key
1398877114
Premarket submission
K232963
Device
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
Applicant
bioMerieux, Inc.
Product code
NGZ
Decision date
2024-06-07