Cleared Traditional

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml

K221899 · Thermo Fisher Scientific · Microbiology
Jan 2023
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K221899 is an FDA 510(k) clearance for the The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml, a Susceptibility Test Plate, Antifungal (Class II — Special Controls, product code NGZ), submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on January 20, 2023, 204 days after receiving the submission on June 30, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K221899 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2022
Decision Date January 20, 2023
Days to Decision 204 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code NGZ — Susceptibility Test Plate, Antifungal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640
Definition The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format.

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