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 |