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FDA 510(k)

驗證®D-二聚體校準驗證/線性測試套件

K 號：K162705 · 2017-01-05

申請人Maine Standards Company, LLC
決定日期2017-01-05
產品代碼GGN
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Maine Standards Company, LLC. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K162705. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit?

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Maine Standards Company, LLC. The 510(k) number is K162705.

When did VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit receive FDA 510(k) clearance?

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit received FDA 510(k) clearance on 2017-01-05, under 510(k) number K162705.

Who is the listed applicant for VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit?

The FDA 510(k) record lists Maine Standards Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit?

The FDA product code for VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit is GGN.

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

其他以 Maine Standards Company, LLC 為申請人之記錄

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。

K170864驗證D-Dimer校準驗證/線性測試套件K163498驗證肝素校準驗證/線性測試套件K152961驗證D-Dimer校準驗證/線性測試套件

相關器械（代碼：GGN）

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。

K170864驗證D-Dimer校準驗證/線性測試套件Maine Standards Company, LLCK163498驗證肝素校準驗證/線性測試套件Maine Standards Company, LLCK161316喬治金·金氏抗凝血劑血液George King Bio-Medical, Inc.K152961驗證D-Dimer校準驗證/線性測試套件Maine Standards Company, LLCK150144視覺康-F 低紺紅素原控制血漿Affinity Biologicals, Inc.

官方來源

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