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FDA 510(k)

Macro & Micro-Test HCG Pregnancy Test Midstream

K-Number: K230741 · 2023-10-13

ApplicantJiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Decision Date2023-10-13
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Macro & Micro-Test HCG Pregnancy Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K230741. 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 Macro & Micro-Test HCG Pregnancy Test Midstream?

Macro & Micro-Test HCG Pregnancy Test Midstream is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. The 510(k) number is K230741.

When did Macro & Micro-Test HCG Pregnancy Test Midstream receive FDA 510(k) clearance?

Macro & Micro-Test HCG Pregnancy Test Midstream received FDA 510(k) clearance on 2023-10-13, under 510(k) number K230741.

Who is the listed applicant for Macro & Micro-Test HCG Pregnancy Test Midstream?

The FDA 510(k) record lists Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Macro & Micro-Test HCG Pregnancy Test Midstream?

The FDA product code for Macro & Micro-Test HCG Pregnancy Test Midstream 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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