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FDA 510(k)

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

K-Number: K230038 · 2023-02-28

ApplicantGuangzhou Decheng Biotechnology Co., Ltd.
Decision Date2023-02-28
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K230038. 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 MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K230038.

When did MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) receive FDA 510(k) clearance?

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) received FDA 510(k) clearance on 2023-02-28, under 510(k) number K230038.

Who is the listed applicant for MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

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

What is the FDA product code for MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

The FDA product code for MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) is LCX.

Other records listing Guangzhou Decheng Biotechnology Co., Ltd. as applicant

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 TestK250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProK242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusK240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamK240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardK232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

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