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FDA 510(k)

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

K-Number: K232864 · 2024-01-26

ApplicantNantong Egens Biotechnology Co., Ltd.
Decision Date2024-01-26
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is the device name listed in this FDA 510(k) record. The listed applicant is Nantong Egens Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K232864. 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 EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Nantong Egens Biotechnology Co., Ltd.. The 510(k) number is K232864.

When did EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II receive FDA 510(k) clearance?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II received FDA 510(k) clearance on 2024-01-26, under 510(k) number K232864.

Who is the listed applicant for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

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

What is the FDA product code for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

The FDA product code for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is LCX.

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., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

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

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