FDA 510(k)

EasyLyte 钠/鈣/氯/鈣分析儀

K 號：K152327 · 2016-12-01

決定日期2016-12-01

產品代碼JFP

諮詢委員會CH

決定相當於

器材摘要

EasyLyte Na/K/Cl/Ca Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corporation. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K152327. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EasyLyte Na/K/Cl/Ca Analyzer?

EasyLyte Na/K/Cl/Ca Analyzer is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Medica Corporation. The 510(k) number is K152327.

When did EasyLyte Na/K/Cl/Ca Analyzer receive FDA 510(k) clearance?

EasyLyte Na/K/Cl/Ca Analyzer received FDA 510(k) clearance on 2016-12-01, under 510(k) number K152327.

Who is the listed applicant for EasyLyte Na/K/Cl/Ca Analyzer?

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

What is the FDA product code for EasyLyte Na/K/Cl/Ca Analyzer?

The FDA product code for EasyLyte Na/K/Cl/Ca Analyzer is JFP.

其他以 Medica Corporation 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。

K220328EasyStat 300 K220396EasyStat 300 K211559EasyStat 300

相關器械（代碼：JFP）

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。

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官方來源

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