FDA 510(k)

直接總膽紅素

K 號：K152343 · 2016-02-16

決定日期2016-02-16

產品代碼JFM

諮詢委員會CH

決定相當於

器材摘要

Direct Bilirubin 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 2016-02-16 under 510(k) number K152343. The device is classified under product code JFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Direct Bilirubin?

Direct Bilirubin is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Randox Laboratories Limited. The 510(k) number is K152343.

When did Direct Bilirubin receive FDA 510(k) clearance?

Direct Bilirubin received FDA 510(k) clearance on 2016-02-16, under 510(k) number K152343.

Who is the listed applicant for Direct Bilirubin?

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 Direct Bilirubin?

The FDA product code for Direct Bilirubin is JFM.

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 K162275Randox RX Daytona Plus 鋁鹼磷酸鹽酶（ALP）K161691直接低密度膽固醇（LDL）K152344總膽紅素

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相關器械（代碼：JFM）

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。

K170065ADVIA® 化學總膽紅素_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.K152344總膽紅素Randox Laboratories Limited

官方來源

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