FDA 510(k)

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

N.º K: K231433 · 2023-08-31

Fecha de decisión2023-08-31

Código de productoNGZ

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K231433.

When did The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL receive FDA 510(k) clearance?

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 510(k) number K231433.

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

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

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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Otros registros que enlistan a Thermo Fisher Scientific como solicitante

K252062El Sistema Sensititre 18-24 hora MIC o Sensibilidad de Punto de Ruptura con Colistina en el rango de dilución de 0.12-16 µg/mL K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL K250990The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL K242843The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL

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Dispositivos relacionados (Código: NGZ)

K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher Scientific K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc.K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.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 K211539Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mLThermo Fisher Scientific

Fuente oficial

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