FDA 510(k)

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream

Número K: K212447 · 2022-02-18

RequerenteHangzhou Sejoy Electronics & Instruments Co., Ltd.

Data da decisão2022-02-18

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Sejoy Electronics & Instruments Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K212447. 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 SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream?

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Hangzhou Sejoy Electronics & Instruments Co., Ltd.. The 510(k) number is K212447.

When did SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream receive FDA 510(k) clearance?

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream received FDA 510(k) clearance on 2022-02-18, under 510(k) number K212447.

Who is the listed applicant for SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream?

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

What is the FDA product code for SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream?

The FDA product code for SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream is LCX.

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