FDA 510(k)

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

Numéro K : K212447 · 2022-02-18

DemandeurHangzhou Sejoy Electronics & Instruments Co., Ltd.

Date de décision2022-02-18

Code produitLCX

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : LCX)

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLC K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Source officielle

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