FDA 510(k)

SAFECARE® THC Urine Strip Test

Número K: K191924 · 2019-08-16

RequerenteSafecare Biotech (Hangzhou) Co., Ltd.

Data da decisão2019-08-16

Código do produtoNFW

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

SAFECARE® THC Urine Strip Test 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 2019-08-16 under 510(k) number K191924. The device is classified under product code NFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SAFECARE® THC Urine Strip Test?

SAFECARE® THC Urine Strip Test is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K191924.

When did SAFECARE® THC Urine Strip Test receive FDA 510(k) clearance?

SAFECARE® THC Urine Strip Test received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191924.

Who is the listed applicant for SAFECARE® THC Urine Strip Test?

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® THC Urine Strip Test?

The FDA product code for SAFECARE® THC Urine Strip Test is NFW.

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

K242767Safecare Urinary Tract Infection Test K240654SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette 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 K182654SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

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Fonte oficial

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