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FDA 510(k)

宏微-HCG懷孕試劑中間流式檢測

K 號：K230741 · 2023-10-13

申請人Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
決定日期2023-10-13
產品代碼LCX
諮詢委員會CH
決定相當於

器材摘要

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.

常見問題

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.

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官方來源

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