FDA 510(k)

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream

Número K: K233174 · 2024-02-05

RequerenteAssure Tech. (Hangzhou) Co, Ltd.

Data da decisão2024-02-05

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2024-02-05 under 510(k) number K233174. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream?

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2024-02-05. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K233174.

When did FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream receive FDA 510(k) clearance?

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2024-02-05, under 510(k) number K233174.

Who is the listed applicant for FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream?

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

What is the FDA product code for FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream?

The FDA product code for FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream is LCX.

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