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FDA 510(k)

alpha-AMYLASE 直接，alpha-AMYLASE EPS，alpha-AMYLASE 胰臟，直接膽紅素，總膽紅素

K 號：K182474 · 2019-05-02

申請人Biosystems S.A.
決定日期2019-05-02
產品代碼JFJ
諮詢委員會CH
決定相當於

器材摘要

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL is the device name listed in this FDA 510(k) record. The listed applicant is Biosystems S.A.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K182474. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL?

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Biosystems S.A.. The 510(k) number is K182474.

When did alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL receive FDA 510(k) clearance?

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL received FDA 510(k) clearance on 2019-05-02, under 510(k) number K182474.

Who is the listed applicant for alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL?

The FDA 510(k) record lists Biosystems S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL?

The FDA product code for alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL is JFJ.

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 Biosystems S.A. 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。

K192730鈣- cresol 磷膽鹼，葡萄糖，尿素/血尿素氮-紫外光K190495轉運蛋白K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

相關器械（代碼：JFJ）

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。

K210633Amylase2Abbott Ireland Diagnostics DivisionK191454Atellica CH 麦芽糖_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.

官方來源

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