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FDA 510(k)

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL

K-Number: K231433 · 2023-08-31

ApplicantThermo Fisher Scientific
Decision Date2023-08-31
Product CodeNGZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL is a medical device manufactured by Thermo Fisher Scientific. It received FDA 510(k) clearance on 2023-08-31 under approval number K231433. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL?

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL is a medical device that received FDA 510(k) clearance on 2023-08-31. It is manufactured by Thermo Fisher Scientific. The 510(k) number is K231433.

When was The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL approved by the FDA?

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL received FDA 510(k) clearance on 2023-08-31, under approval number K231433.

What company makes The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL?

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL is manufactured by Thermo Fisher Scientific.

What is the FDA product code for The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL?

The FDA product code for The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL is NGZ.

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Other Devices by Thermo Fisher Scientific

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Related Devices (Code: NGZ)

K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)bioMerieux, Inc. K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc. K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)bioMerieux, Inc. K211539Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mLThermo Fisher Scientific K221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mLThermo Fisher Scientific K221899The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/mlThermo Fisher Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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