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FDA 510(k)

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip

K-Number: K241394 · 2024-12-20

ApplicantAndon Health Co, Ltd.
Decision Date2024-12-20
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2024-12-20 under approval number K241394. 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 iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip?

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K241394.

When was iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip approved by the FDA?

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip received FDA 510(k) clearance on 2024-12-20, under approval number K241394.

What company makes iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip?

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip is manufactured by Andon Health Co, Ltd..

What is the FDA product code for iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip?

The FDA product code for iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip is LCX.

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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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