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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar2Product Code
- JTNSusceptibility Test Discs, Antimicrobial2Product Code
- JTTSusceptibility Test Powders, Antimicrobial2Product Code
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth2Product Code
- JWYManual Antimicrobial Susceptibility Test Systems2Product Code
- LIEReagent/Device, Inoculum Calibration2Product Code
- LKACulture Media, Antimicrobial Susceptibility Test2Product Code
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation2Product Code
- LOPSolution, Antimicrobial2Product Code
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems2Product Code
- LTTPanels, Test, Susceptibility, Antimicrobial2Product Code
- LTWSusceptibility Test Cards, Antimicrobial2Product Code
- LTXDiscs, Elution2Product Code
- MJASusceptibility Test Powders, Antimycobacterial2Product Code
- MJDCulture Media, Antimycobacteria, Susceptibility Test2Product Code
- MJECulture Media, Antifungal, Susceptibility Test2Product Code
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies2Product Code
- NGZSusceptibility Test Plate, Antifungal2Product Code
- K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL2Cleared 510(K)
- K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)2Cleared 510(K)
- K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)2Cleared 510(K)
- K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL2Cleared 510(K)
- K221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL2Cleared 510(K)
- K221899The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml2Cleared 510(K)
- K211539Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL2Cleared 510(K)
- K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)2Cleared 510(K)
- K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)2Cleared 510(K)
- K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL2Cleared 510(K)
Show All 21 Submissions
- NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species2Product Code
- NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen2Product Code
- PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony2Product Code
- POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen2Product Code
- PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates2Product Code
- QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay2Product Code
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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- UnknownReview Panel
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K243738
- 510(k) Type
- Traditional
- Applicant
- Thermo Fisher Scientific
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/27/2025
- Days to Decision
- 85 days
- Submission Type
- Statement