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FDA 510(k)

Assure Tech hCG 孕婦血清/尿液組合試劑盒，Assure Tech hCG 孕婦血清/尿液組合試劑條

K 號：K152768 · 2016-02-24

申請人Assure Tech. Co., Ltd.
決定日期2016-02-24
產品代碼JHI
諮詢委員會CH
決定相當於

器材摘要

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. Co., Ltd.. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K152768. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip?

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Assure Tech. Co., Ltd.. The 510(k) number is K152768.

When did Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip receive FDA 510(k) clearance?

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip received FDA 510(k) clearance on 2016-02-24, under 510(k) number K152768.

Who is the listed applicant for Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip?

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

What is the FDA product code for Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip?

The FDA product code for Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is JHI.

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：JHI）

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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