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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 the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) 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. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K241394.

When did iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip receive FDA 510(k) clearance?

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

Who is the listed applicant for iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip?

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

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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., LLCK242135Synthgene 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., LLCK240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)Anhui Deepblue Medical Technology Co., Ltd.

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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