FDA 510(k)

DUS R-50S（尿液化學系統）

K 號：K171521 · 2018-02-16

決定日期2018-02-16

產品代碼JIL

諮詢委員會CH

決定相當於

器材摘要

DUS R-50S (Urine Chemistry system) is the device name listed in this FDA 510(k) record. The listed applicant is DFI Co., Ltd.. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K171521. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DUS R-50S (Urine Chemistry system)?

DUS R-50S (Urine Chemistry system) is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is DFI Co., Ltd.. The 510(k) number is K171521.

When did DUS R-50S (Urine Chemistry system) receive FDA 510(k) clearance?

DUS R-50S (Urine Chemistry system) received FDA 510(k) clearance on 2018-02-16, under 510(k) number K171521.

Who is the listed applicant for DUS R-50S (Urine Chemistry system)?

The FDA 510(k) record lists DFI Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUS R-50S (Urine Chemistry system)?

The FDA product code for DUS R-50S (Urine Chemistry system) is JIL.

其他以 DFI Co., Ltd. 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。

K181024DUS 2GP試劑條，DUS 5試劑條，DUS 10試劑條

相關器械（代碼：JIL）

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。

K193514AUTION MAX AX-4060 尿檢分析系統Arkray, Inc.K183432cobas u 601 尿分析測試系統Roche Diagnostics K173327DIP/美國尿檢分析測試系統Healthy.Io, Ltd.K180356inui 遊宅尿液分析測試系統Scanadu, Inc.K181024DUS 2GP試劑條，DUS 5試劑條，DUS 10試劑條DFI Co., Ltd.K171083iChemVELOCITY自動尿化學系統Iris Diagnostics, A Division of Iris International, Inc.

官方來源

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