VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL— 510(k) K151817
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K151817 for VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL, Substantially Equivalent on 2016-02-18. 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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