FDA 510(k)

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

Número K: K240654 · 2024-04-10

RequerenteSafecare Biotech (Hangzhou) Co., Ltd.

Data da decisão2024-04-10

Código do produtoNGL

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Safecare Biotech (Hangzhou) Co., Ltd. como candidato(a)

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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Fonte oficial

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