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FDA 510(k)

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

K-Number: K212447 · 2022-02-18

ApplicantHangzhou Sejoy Electronics & Instruments Co., Ltd.
Decision Date2022-02-18
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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 manufactured by Hangzhou Sejoy Electronics & Instruments Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under approval number K212447. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Hangzhou Sejoy Electronics & Instruments Co., Ltd.. The 510(k) number is K212447.

When was SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream approved by the FDA?

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 approval number K212447.

What company makes 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 manufactured by Hangzhou Sejoy Electronics & Instruments Co., Ltd..

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.

Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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