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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 a medical device manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-10-13 under approval 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. It is manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. The 510(k) number is K230741.

When was Macro & Micro-Test HCG Pregnancy Test Midstream approved by the FDA?

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

What company makes Macro & Micro-Test HCG Pregnancy Test Midstream?

Macro & Micro-Test HCG Pregnancy Test Midstream is manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd..

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.

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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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