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FDA 510(k)

Synthgene 首頁測試 HCG 測試條；Synthgene 首頁測試 HCG 測試卡式；Synthgene 首頁測試 HCG 測試中間流

K 號：K242135 · 2025-01-31

申請人Nanjing Synthgene Medical Technology Co., Ltd.
決定日期2025-01-31
產品代碼LCX
諮詢委員會CH
決定相當於

器材摘要

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Synthgene Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K242135. 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 Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Nanjing Synthgene Medical Technology Co., Ltd.. The 510(k) number is K242135.

When did Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream receive FDA 510(k) clearance?

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream received FDA 510(k) clearance on 2025-01-31, under 510(k) number K242135.

Who is the listed applicant for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

The FDA 510(k) record lists Nanjing Synthgene Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream?

The FDA product code for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream is LCX.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：LCX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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