FDA 510(k)

Teco 酶法肌酐試劑組

K 號：K161527 · 2017-07-21

決定日期2017-07-21

產品代碼JFY

諮詢委員會CH

決定相當於

器材摘要

Teco Creatinine Enzymatic Reagent Kit is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K161527. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Teco Creatinine Enzymatic Reagent Kit?

Teco Creatinine Enzymatic Reagent Kit is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Teco Diagnostics, Inc.. The 510(k) number is K161527.

When did Teco Creatinine Enzymatic Reagent Kit receive FDA 510(k) clearance?

Teco Creatinine Enzymatic Reagent Kit received FDA 510(k) clearance on 2017-07-21, under 510(k) number K161527.

Who is the listed applicant for Teco Creatinine Enzymatic Reagent Kit?

The FDA 510(k) record lists Teco Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Teco Creatinine Enzymatic Reagent Kit?

The FDA product code for Teco Creatinine Enzymatic Reagent Kit is JFY.

其他以 Teco Diagnostics, Inc. 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。

K170200二氧化碳試劑組 K160372URITEK TC-201 尿液化學檢測系統 K152835URITEK TC-201 尿液化學檢測系統

相關器械（代碼：JFY）

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。

K252619QSCHECK 医療設備規範文本 QSCHECK 医療設備規範文本Qstag, Inc.K212223Atellica CH 酶促性肌酸酐_3 (ECre3)Siemens Healthcare Diagnostics, Inc.K193649裕米森C1200肌肝酐PAPHORIBA ABX SAS K182384ACR LAB 尿液分析測試系統Healthy.Io, Ltd.K183555GEM預警者化學狀態監測系統Instrumentation Laboratory CO K182038URiSCAN 10ACR 尿試紙於URiSCAN Optima 尿分析儀上Yd Diagnostics Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。