FDA 510(k)

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

Número K: K201120 · 2020-05-27

RequerenteSafecare Biotech (Hangzhou) Co., Ltd.

Data da decisão2020-05-27

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card 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 2020-05-27 under 510(k) number K201120. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K201120.

When did SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card receive FDA 510(k) clearance?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card received FDA 510(k) clearance on 2020-05-27, under 510(k) number K201120.

Who is the listed applicant for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

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 Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

The FDA product code for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is NFT.

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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 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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