FDA 510(k)

Randox RX Daytona Plus 鋁鹼磷酸鹽酶（ALP）

K 號：K162275 · 2017-04-21

決定日期2017-04-21

產品代碼CJE

諮詢委員會CH

決定相當於

器材摘要

Randox RX Daytona Plus Alkaline Phosphatase (ALP) is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K162275. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Randox RX Daytona Plus Alkaline Phosphatase (ALP)?

Randox RX Daytona Plus Alkaline Phosphatase (ALP) is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Randox Laboratories Limited. The 510(k) number is K162275.

When did Randox RX Daytona Plus Alkaline Phosphatase (ALP) receive FDA 510(k) clearance?

Randox RX Daytona Plus Alkaline Phosphatase (ALP) received FDA 510(k) clearance on 2017-04-21, under 510(k) number K162275.

Who is the listed applicant for Randox RX Daytona Plus Alkaline Phosphatase (ALP)?

The FDA 510(k) record lists Randox Laboratories Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Randox RX Daytona Plus Alkaline Phosphatase (ALP)?

The FDA product code for Randox RX Daytona Plus Alkaline Phosphatase (ALP) is CJE.

其他以 Randox Laboratories Limited 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。

K250741證據 MultiSTAT 死亡尿多聯合 K220451證據多項測試尿檢MultiSTAT，證據多項測試MultiSTAT K221550證據 MultiSTAT 死亡尿多聯合 K161691直接低密度膽固醇（LDL）K152343直接總膽紅素 K152344總膽紅素

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相關器械（代碼：CJE）

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。

K251074真肝健康檢測組合Truvian Health K240468鹼性磷酸鹽Abbott Laboratories Diagnostics Division K223317鹼性磷酸鹽2Abbott Ireland Diagnostics Division K191245裕米森C1200 ALP，裕米森C1200白蛋白HORIBA ABX SAS K171971全套代謝檢查、skyla 臨床化學分析儀、Minicare C300 臨床化學分析儀Lite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

官方來源

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