FDA 510(k)

KET-1 血糖酮體監測系統

K 號：K182593 · 2018-12-18

決定日期2018-12-18

產品代碼JIN

諮詢委員會CH

決定相當於

器材摘要

KET-1 Blood Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2018-12-18 under 510(k) number K182593. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KET-1 Blood Ketone Monitoring System?

KET-1 Blood Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K182593.

When did KET-1 Blood Ketone Monitoring System receive FDA 510(k) clearance?

KET-1 Blood Ketone Monitoring System received FDA 510(k) clearance on 2018-12-18, under 510(k) number K182593.

Who is the listed applicant for KET-1 Blood Ketone Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KET-1 Blood Ketone Monitoring System?

The FDA product code for KET-1 Blood Ketone Monitoring System is JIN.

其他以 Apex BioTechnology Corp. 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。

K242209UASure II 血鹼酸監測系統 K222234GlucoSure ADVANCE 鏈接血糖監測系統 K220421BGM039 血糖監測系統，BGM039 鏈接血糖監測系統 K212140GlucoSure Link 血糖監測系統 K202534MTM301 血糖及酮體監測系統 K213887GAL-1A Plus 適用醫療設備監管系統

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相關器械（代碼：JIN）

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。

K201551KetoSens BT 血糖酮體監測系統I-Sens, Inc.K192957VivaChek 血糖及B-酮體監測系統Vivachek Biotech (Hangzhou) Co., Ltd.K173345TD-4140 智能轉接器血糖加B-酮體監測系統Taidoc Technology Corporation K170463KetoSens 血糖B-酮體監測系統，KetoSens 多功能血B-酮體監測系統I-Sens, Inc.K170587即時酮體試劑條，用於尿液化驗；健康我酮體試劑條，用於尿液化驗ACON Laboratories, Inc.

官方來源

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