510(k) clearances

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

Thermo Fisher Scientific · Microbiology

K243738Substantially EquivalentTraditionalNGZ
Open FDA's page for this record
Third party flag
N
City
Oakwood Village
Advisory committee description
Microbiology
Address 1
1 Thermofisher Way
Statement or summary
Statement
Product code
NGZ
Zip code
44146
Applicant
Thermo Fisher Scientific
Decision date
2025-02-27
Decision code
SESE
Country code
US
Device name
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
Advisory committee
MI
Contact
Joel Mathew
K number
K243738
State
OH
Date received
2024-12-04
Review advisory committee
MI
Postal code
44146
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Susceptibility Test Plate, Antifungal
Medical specialty description
Microbiology
Regulation number
866.1640
Device class
2
Registration number
1530126, 3003750284, 3013718871, 3031977134, 8021914, 1924669, 9615754, 1950204
FEI number
3002806332, 3008237827, 1000515493, 3003750284, 3013718871, 3031977134, 1924669, 1950204
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.