FDA 510(k)

TransFix/EDTA 真空血液採集管

K 號：K162723 · 2017-06-22

決定日期2017-06-22

產品代碼GIM

諮詢委員會CH

決定相當於

器材摘要

TransFix/EDTA Vacuum Blood Collection Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Caltag Medsystems, Ltd.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K162723. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TransFix/EDTA Vacuum Blood Collection Tubes?

TransFix/EDTA Vacuum Blood Collection Tubes is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Caltag Medsystems, Ltd.. The 510(k) number is K162723.

When did TransFix/EDTA Vacuum Blood Collection Tubes receive FDA 510(k) clearance?

TransFix/EDTA Vacuum Blood Collection Tubes received FDA 510(k) clearance on 2017-06-22, under 510(k) number K162723.

Who is the listed applicant for TransFix/EDTA Vacuum Blood Collection Tubes?

The FDA 510(k) record lists Caltag Medsystems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TransFix/EDTA Vacuum Blood Collection Tubes?

The FDA product code for TransFix/EDTA Vacuum Blood Collection Tubes is GIM.

相關器械（代碼：GIM）

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：GIM）

官方來源