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FDA 510(k)

Diatron Pictus 700 醫學化學分析儀,Diatron ISE,Diatron 葡萄糖己糖激酶法

K 號:K151487 · 2016-01-14

決定日期2016-01-14
產品代碼CFR
諮詢委員會CH
決定相當於

器材摘要

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method is the device name listed in this FDA 510(k) record. The listed applicant is Diatron U.S., Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K151487. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method?

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Diatron U.S., Inc.. The 510(k) number is K151487.

When did Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method receive FDA 510(k) clearance?

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method received FDA 510(k) clearance on 2016-01-14, under 510(k) number K151487.

Who is the listed applicant for Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method?

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

What is the FDA product code for Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method?

The FDA product code for Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method is CFR.

相關臨床試驗

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相關器械(代碼:CFR)

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。

官方來源

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