FDA 510(k)

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

N.º K: K192301 · 2019-09-20

SolicitanteShenzhen Bioeasy Biotechnology Co., Ltd.

Fecha de decisión2019-09-20

Código de productoNFW

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K192301. The device is classified under product code NFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip?

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K192301.

When did BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip receive FDA 510(k) clearance?

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip received FDA 510(k) clearance on 2019-09-20, under 510(k) number K192301.

Who is the listed applicant for BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip?

The FDA 510(k) record lists Shenzhen Bioeasy Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip?

The FDA product code for BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is NFW.

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Otros registros que enlistan a Shenzhen Bioeasy Biotechnology Co., Ltd. como solicitante

K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx K193480BIOEASY Multi-Drug Test Cup K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 K182530BIOEASY Multi-Drug Test Cup

Dispositivos relacionados (Código: NFW)

K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC K231978BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50Vivachek Biotech (Hangzhou) Co., Ltd.K191924SAFECARE® THC Urine Strip TestSafecare Biotech (Hangzhou) Co., Ltd.

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.