VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)— 510(k) K232963
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K232963 for VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL), Substantially Equivalent on 2024-06-07. Applicant: bioMerieux, Inc.. Device class: 2.
Clearance details
- Applicant
- bioMerieux, Inc.
- Product code
- Code NGZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
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More clearances from bioMerieux, Inc.
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