FDA 510(k)

CellaVision DC-1, CellaVision DC-1 PPA

K 號：K200595 · 2020-10-16

決定日期2020-10-16

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

CellaVision DC-1, CellaVision DC-1 PPA is the device name listed in this FDA 510(k) record. The listed applicant is CellaVision AB. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K200595. 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 CellaVision DC-1, CellaVision DC-1 PPA?

CellaVision DC-1, CellaVision DC-1 PPA is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is CellaVision AB. The 510(k) number is K200595.

When did CellaVision DC-1, CellaVision DC-1 PPA receive FDA 510(k) clearance?

CellaVision DC-1, CellaVision DC-1 PPA received FDA 510(k) clearance on 2020-10-16, under 510(k) number K200595.

Who is the listed applicant for CellaVision DC-1, CellaVision DC-1 PPA?

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 CellaVision DC-1, CellaVision DC-1 PPA?

The FDA product code for CellaVision DC-1, CellaVision DC-1 PPA 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。

K171315先進紅血球應用

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.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.K171315先進紅血球應用CellaVision AB

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