VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)— 510(k) K181368
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K181368 for VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL), Substantially Equivalent on 2018-06-20. Applicant: bioMerieux, Inc..
Clearance details
- Applicant
- bioMerieux, Inc.
- Product code
- Code NGZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hazelwood, MO, US
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