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 |
| K232963 | bioMerieux, Inc. | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 ╡g/mL) | 06/07/2024 |
| K151923 | BIOMERIEUX, INC. | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | 03/25/2016 |
| K232967 | bioMerieux, Inc. | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 ╡g/mL) | 06/12/2024 |
| 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 |
| K243738 | Thermo Fisher Scientific | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 ╡g/mL | 02/27/2025 |
| 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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