Cleared Traditional

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

K221198 · Thermo Fisher Scientific · Microbiology
Mar 2023
Decision
318d
Days
Class 2
Risk

About This 510(k) Submission

K221198 is an FDA 510(k) clearance for the Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/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 March 10, 2023, 318 days after receiving the submission on April 26, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K221198 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2022
Decision Date March 10, 2023
Days to Decision 318 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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