FDA 510(k)

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

N.º K: K240654 · 2024-04-10

SolicitanteSafecare Biotech (Hangzhou) Co., Ltd.

Fecha de decisión2024-04-10

Código de productoNGL

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K240654. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K240654.

When did SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette receive FDA 510(k) clearance?

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette received FDA 510(k) clearance on 2024-04-10, under 510(k) number K240654.

Who is the listed applicant for SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

The FDA 510(k) record lists Safecare Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

The FDA product code for SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is NGL.

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Otros registros que enlistan a Safecare Biotech (Hangzhou) Co., Ltd. como solicitante

K242767Safecare Urinary Tract Infection Test K202453SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream K201120SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card K191924SAFECARE® THC Urine Strip Test K182654SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

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Dispositivos relacionados (Código: NGL)

K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLC K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusGuangzhou Decheng Biotechnology Co., Ltd.K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLC K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.

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.