When did VITEK 2 AST-YS Caspofungin =8 ug/mL receive FDA 510(k) clearance?

VITEK 2 AST-YS Caspofungin =8 ug/mL received FDA 510(k) clearance on 2016-02-18, under 510(k) number K151817.

FDA 510(k)

VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL

N.º K: K151817 · 2016-02-18

SolicitantebioMerieux, Inc.

Fecha de decisión2016-02-18

Código de productoNGZ

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/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 2016-02-18 under 510(k) number K151817. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL?

VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is bioMerieux, Inc.. The 510(k) number is K151817.

When did VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL receive FDA 510(k) clearance?

VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL received FDA 510(k) clearance on 2016-02-18, under 510(k) number K151817.

Who is the listed applicant for VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/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-YS Caspofungin <=0.125 - >=8 ug/mL?

The FDA product code for VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL is NGZ.

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Otros registros que enlistan a bioMerieux, Inc. como solicitante

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 K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

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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 K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc.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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.