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FDA 510(k)

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

N.º K: K192001 · 2019-10-22

SolicitanteSterilucent, Inc.
Fecha de decisión2019-10-22
Código de productoFRC
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is the device name listed in this FDA 510(k) record. The listed applicant is Sterilucent, Inc.. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K192001. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Sterilucent, Inc.. The 510(k) number is K192001.

When did Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device receive FDA 510(k) clearance?

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device received FDA 510(k) clearance on 2019-10-22, under 510(k) number K192001.

Who is the listed applicant for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

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

What is the FDA product code for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

The FDA product code for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is FRC.

Ensayos clínicos relacionados

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Otros registros que enlistan a Sterilucent, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K191999Sterilucent VH2O2 Chemical IndicatorsK190005Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

Dispositivos relacionados (Código: FRC)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK250061Celerity IncubatorSTERIS Corporation

Fuente oficial

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

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