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FDA 510(k), K181368, VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
FDA 510(k), K181368, VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
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510(K) Number: K181368
Device Name: VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
Manufacturer: bioMerieux, Inc.
Device Classification Name: susceptibility test plate, antifungal
Regulation Number: 866.1640
Classification Product Code: NGZ
Date Received: 05/23/2018
Decision Date: 06/20/2018
Regulation Medical Specialty: Microbiology
Device Name: VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
Manufacturer: bioMerieux, Inc.
Device Classification Name: susceptibility test plate, antifungal
Regulation Number: 866.1640
Classification Product Code: NGZ
Date Received: 05/23/2018
Decision Date: 06/20/2018
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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