FDA.reportPublic FDA data

510(k) K232963

Device
VITEK 2 AST-Yeast Anidulafungin (= 8 µg/mL)
Applicant
bioMerieux, Inc.
510(k) number
K232963
Product code
NGZ
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-07
Date received
2023-09-21
Regulation
866.1640
Classification name
Susceptibility Test Plate, Antifungal
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Esther Hernandez
Address
595 Anglum Rd. Hazelwood MO US 63042 63042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NGZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher Scientific2025-02-27
K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc.2024-06-12
K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific2023-08-31
K221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mLThermo Fisher Scientific2023-03-10
K221899The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/mlThermo Fisher Scientific2023-01-20
K211539Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mLThermo Fisher Scientific2021-12-15
K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)bioMerieux, Inc.2018-06-20
K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)bioMerieux, Inc.2016-03-25
K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc.2016-02-18
K133952VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINEbioMerieux, Inc.2014-08-19
K133817VITEK 2 AST - YEAST FLUCONAZOLEbioMerieux, Inc.2014-08-05
K133038SENSITITRE YEASTONE SUSCEPTIBILITY PLATESTrek Diagnostic Systems2014-01-31
K101566VITEK 2 YEAST CASPOFUNGINbioMerieux, Inc.2010-09-28
K092454VITEK 2 YEAST VORICONAZOLEbioMerieux, Inc.2010-05-21
K082534ETEST VORICONAZOLE 0.002-32 UG/MLAb Biomerieux2009-11-02