FDA 510(k)

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL

Numéro K : K243738 · 2025-02-27

Date de décision2025-02-27

Code produitNGZ

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/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 2025-02-27 under 510(k) number K243738. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL?

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K243738.

When did The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL receive FDA 510(k) clearance?

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL received FDA 510(k) clearance on 2025-02-27, under 510(k) number K243738.

Who is the listed applicant for The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/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 Micafungin in the dilution range of 0.008-16 µg/mL?

The FDA product code for The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL is NGZ.

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Dispositifs connexes (Code : NGZ)

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Source officielle

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