FDA 510(k)

GEM預警者化學狀態監測系統

K 號：K183555 · 2019-02-16

決定日期2019-02-16

產品代碼JFY

諮詢委員會CH

決定相當於

器材摘要

GEM Premier ChemSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2019-02-16 under 510(k) number K183555. 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 GEM Premier ChemSTAT?

GEM Premier ChemSTAT is a medical device that received FDA 510(k) clearance on 2019-02-16. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K183555.

When did GEM Premier ChemSTAT receive FDA 510(k) clearance?

GEM Premier ChemSTAT received FDA 510(k) clearance on 2019-02-16, under 510(k) number K183555.

Who is the listed applicant for GEM Premier ChemSTAT?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM Premier ChemSTAT?

The FDA product code for GEM Premier ChemSTAT is JFY.

其他以 Instrumentation Laboratory CO 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。

K221359ACL TOP 970 CL, HemosIL CL 抗心磷脂IgM, HemosIL CL 抗ß2 糖蛋白-I IgM K223187HemosIL 液體抗-Xa K223090GEM預警者化學狀態監測系統 K223402HemosIL 遺傳性血友病因子抗原 K213464HemosIL 液體抗-Xa K213426HemosIL ReadiPlasTin

查看所有 25 項裝置 →

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.K182038URiSCAN 10ACR 尿試紙於URiSCAN Optima 尿分析儀上Yd Diagnostics Corporation K182063VITROS化學產品CRBM薄片，VITROS化學產品CREA薄片，VITROS化學產品TBIL薄片，VITROS XT 7600整合系統Ortho-Clinical Diagnostics, Inc.

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。