FDA 510(k)

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument

K号: K163274 · 2017-04-05

决定日期2017-04-05

产品代码JOZ

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Aggredyne, Inc.为申报人的其他记录

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K181777AggreGuide A-100 ADP

官方来源

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