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FDA 510(k)

Nephrocheck測試套件，ASTUTE140計量儀，Nephrocheck液體控制套件，Nephrocheck校準驗證（校驗Vers）套件

K 號：K153165 · 2016-06-01

申請人Astute Medical, Inc.
決定日期2016-06-01
產品代碼PIG
諮詢委員會CH
決定相當於

器材摘要

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit is the device name listed in this FDA 510(k) record. The listed applicant is Astute Medical, Inc.. It received FDA 510(k) clearance on 2016-06-01 under 510(k) number K153165. The device is classified under product code PIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit?

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit is a medical device that received FDA 510(k) clearance on 2016-06-01. The listed applicant is Astute Medical, Inc.. The 510(k) number is K153165.

When did NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit receive FDA 510(k) clearance?

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit received FDA 510(k) clearance on 2016-06-01, under 510(k) number K153165.

Who is the listed applicant for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit?

The FDA 510(k) record lists Astute Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit?

The FDA product code for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit is PIG.

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 Astute Medical, Inc. 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。

K171482Nephrocheck測試系統

相關器械（代碼：PIG）

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。

K232761ProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc.K210793VIDAS 腎功能檢查Biomérieux SAK171482Nephrocheck測試系統Astute Medical, Inc.

官方來源

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