FDA 510(k)

SelectaLyte 電解質分析儀（Na+、K+、Cl-）

K 號：K171476 · 2018-02-27

決定日期2018-02-27

產品代碼JGS

諮詢委員會CH

決定相當於

器材摘要

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is the device name listed in this FDA 510(k) record. The listed applicant is Awareness Technology, Inc.. It received FDA 510(k) clearance on 2018-02-27 under 510(k) number K171476. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)?

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is a medical device that received FDA 510(k) clearance on 2018-02-27. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K171476.

When did SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) receive FDA 510(k) clearance?

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) received FDA 510(k) clearance on 2018-02-27, under 510(k) number K171476.

Who is the listed applicant for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)?

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

What is the FDA product code for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)?

The FDA product code for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is JGS.

相關器械（代碼：JGS）

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。

K252475ABL90 FLEX PLUS 系統Radiometer Medicals Aps K230275i-STAT CG8+ 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.K222438A-LYTE® 集成多感知器（IMT Na K Cl）Siemens Healthcare Diagnostics, Inc.K220977ISE試劑，葡萄糖，CRP膠乳，DxC 500 AU臨床化學分析儀Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP系統追蹤Abbott Laboratories K200403統計配置文件Prime Plus分析系統Nova Biomedical 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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JGS）

官方來源