VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)— 510(k) K232967

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K232967 for VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL), Substantially Equivalent on 2024-06-12. Applicant: bioMerieux, Inc..

Clearance details

Applicant
bioMerieux, Inc.
Product code
Code NGZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hazelwood, MO, US
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