510(k) K181368
- Device
- VITEK 2 AST-YS Micafungin (8 µg/mL)
- Applicant
- BioMerieux, Inc.
- 510(k) number
- K181368
- Product code
- NGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-20
- Date received
- 2018-05-23
- Regulation
- 866.1640
- Classification name
- Susceptibility Test Plate, Antifungal
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jolyn Tenllado
- Address
- 595 Anglum Rd. Hazelwood MO US 63042 63042
FDA Registration Numbers#
- 3031977134
- 1530126
- 1924669
- 9615754
- 1950204
- 8021914
- 3013718871
- 3003750284
Source Documents#
Other 510(k) Records For Product Code NGZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific | 2025-02-27 |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | bioMerieux, Inc. | 2024-06-12 |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | bioMerieux, Inc. | 2024-06-07 |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | Thermo Fisher Scientific | 2023-08-31 |
| K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL | Thermo Fisher Scientific | 2023-03-10 |
| K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml | Thermo Fisher Scientific | 2023-01-20 |
| K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL | Thermo Fisher Scientific | 2021-12-15 |
| K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | bioMerieux, Inc. | 2016-03-25 |
| K151817 | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL | bioMerieux, Inc. | 2016-02-18 |
| K133952 | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE | bioMerieux, Inc. | 2014-08-19 |
| K133817 | VITEK 2 AST - YEAST FLUCONAZOLE | bioMerieux, Inc. | 2014-08-05 |
| K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Trek Diagnostic Systems | 2014-01-31 |
| K101566 | VITEK 2 YEAST CASPOFUNGIN | bioMerieux, Inc. | 2010-09-28 |
| K092454 | VITEK 2 YEAST VORICONAZOLE | bioMerieux, Inc. | 2010-05-21 |
| K082534 | ETEST VORICONAZOLE 0.002-32 UG/ML | Ab Biomerieux | 2009-11-02 |
Legacy Summary#
summary
FDA Review#
Decision Summary