FDA 510(k)

先進紅血球應用

K 號：K171315 · 2017-08-01

決定日期2017-08-01

產品代碼JOY

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

Advanced RBC Application is the device name listed in this FDA 510(k) record. The listed applicant is CellaVision AB. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K171315. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advanced RBC Application?

Advanced RBC Application is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is CellaVision AB. The 510(k) number is K171315.

When did Advanced RBC Application receive FDA 510(k) clearance?

Advanced RBC Application received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171315.

Who is the listed applicant for Advanced RBC Application?

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

What is the FDA product code for Advanced RBC Application?

The FDA product code for Advanced RBC Application is JOY.

其他以 CellaVision AB 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。

K200595CellaVision DC-1, CellaVision DC-1 PPA

相關器械（代碼：JOY）

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。

K243144X100/X100HT 內建全場域周邊血液涂片（PBS）應用Scopio Labs , Ltd.K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.K220013X100HT 配備滑動加載器，全場周邊血液涂片（PBS）應用Scopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB K201301X100 配合全場周邊血液涂片（PBS）應用Scopio Labs , Ltd.K182062Sysmex UD-10，全自動尿沉渣數位影像設備Sysmex America, Inc.

官方來源

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