FDA 510(k)

AggreGuide A-100 AA Assay, AggreGuide A-100儀器

K 號：K163274 · 2017-04-05

決定日期2017-04-05

產品代碼JOZ

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

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Aggredyne, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K163274. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument?

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Aggredyne, Inc.. The 510(k) number is K163274.

When did AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument receive FDA 510(k) clearance?

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument received FDA 510(k) clearance on 2017-04-05, under 510(k) number K163274.

Who is the listed applicant for AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument?

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

What is the FDA product code for AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument?

The FDA product code for AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument is JOZ.

其他以 Aggredyne, Inc. 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。

K181777AggreGuide A-100 ADP

相關器械（代碼：JOZ）

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。

K191364T-TAS 01 全血栓形成分析系統儀器，T-TAS 01 用 PL 芯片，T-TAS 01 用 PL 芯片儲液組，T-TAS 01 用 BAPA 管子Fujimori Kogyo, Co., Ltd.K181777AggreGuide A-100 ADPAggredyne, Inc.K161329時鐘記錄血小板聚集儀，4通道；時鐘記錄血小板聚集儀，8通道Chrono-Log Corp.

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