FDA 510(k) Applications for Medical Device Product Code "NGZ"
(Susceptibility Test Plate, Antifungal)

FDA 510(k) Number Applicant Device Name Decision Date
K040560 AB BIODISK ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING 07/27/2004
K082534 AB BIOMERIEUX ETEST VORICONAZOLE 0.002-32 UG/ML 11/02/2009
K151817 BIOMERIEUX INC VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL 02/18/2016
K133817 BIOMERIEUX, INC. VITEK 2 AST - YEAST FLUCONAZOLE 08/05/2014
K133952 BIOMERIEUX, INC. VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE 08/19/2014
K151923 BIOMERIEUX, INC. VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) 03/25/2016
K061945 BIOMERIEUX, INC. VITEK 2 AST-YS FLUCONAZOLE 09/19/2006
K181368 bioMerieux, Inc. VITEK 2 AST-YS Micafungin (<=0.06 - =>8 ╡g/mL) 06/20/2018
K101566 BIOMERIEUX, INC. VITEK 2 YEAST CASPOFUNGIN 09/28/2010
K092454 BIOMERIEUX, INC. VITEK 2 YEAST VORICONAZOLE 05/21/2010
K221198 Thermo Fisher Scientific Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL 03/10/2023
K211539 Thermo Fisher Scientific Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL 12/15/2021
K221899 Thermo Fisher Scientific The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml 01/20/2023
K231433 Thermo Fisher Scientific The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL 08/31/2023
K133038 TREK DIAGNOSTIC SYSTEMS SENSITITRE YEASTONE SUSCEPTIBILITY PLATES 01/31/2014
K991810 TREK DIAGNOSTIC SYSTEMS, INC. MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST 10/09/2001
K090968 TREK DIAGNOSTIC SYSTEMS, INC. SENSITITRE YEASTONE SUSCEPTIBILITY PLATES 06/04/2009
K081063 TREK DIAGNOSTIC SYSTEMS, INC. SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS 03/06/2009


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