When did VITEK 2 AST-Yeast Voriconazole ( = 4 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Yeast Voriconazole ( = 4 µg/mL) received FDA 510(k) clearance on 2024-06-12, under 510(k) number K232967.

FDA 510(k)

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

Número K: K232967 · 2024-06-12

RequerentebioMerieux, Inc.

Data da decisão2024-06-12

Código do produtoNGZ

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K232967. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)?

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is bioMerieux, Inc.. The 510(k) number is K232967.

When did VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) received FDA 510(k) clearance on 2024-06-12, under 510(k) number K232967.

Who is the listed applicant for VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)?

The FDA product code for VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) is NGZ.

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Outros registros que listam bioMerieux, Inc. como candidato(a)

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST System K260282VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)K234012VITEK COMPACT PRO K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)K240279VIDAS TBI (GFAP, UCH-L1)

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Dispositivos Relacionados (Código: NGZ)

K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher Scientific K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific K221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mLThermo Fisher Scientific K221899The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/mlThermo Fisher Scientific K211539Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mLThermo Fisher Scientific

Fonte oficial

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