Atlas FDA

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

FDA 510(k) clearance K133038 · decided 2014-01-31

Clearance details

K-number
K133038
Device name
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
Applicant
Trek Diagnostic Systems
Decision
Substantially Equivalent
Date received
2013-09-26
Decision date
2014-01-31
Days to decision
127 days
Clearance type
Traditional
Product code
NGZ
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Oakwood Village, OH, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (K243738)Thermo Fisher Scientific2025-02-27
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (K232967)bioMerieux, Inc.2024-06-12
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (K232963)bioMerieux, Inc.2024-06-07
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL (K231433)Thermo Fisher Scientific2023-08-31
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198)Thermo Fisher Scientific2023-03-10
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899)Thermo Fisher Scientific2023-01-20
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL (K211539)Thermo Fisher Scientific2021-12-15
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (K181368)bioMerieux, Inc.2018-06-20
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (K151923)bioMerieux, Inc.2016-03-25
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (K151817)bioMerieux, Inc.2016-02-18
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (K133952)bioMerieux, Inc.2014-08-19
VITEK 2 AST - YEAST FLUCONAZOLE (K133817)bioMerieux, Inc.2014-08-05

Recalls involving this device

No recalls on record reference this clearance.