FDA 510(k)

iC-GN iC-卡式盒，适用于iC-系统

K号: K190341 · 2019-06-28

决定日期2019-06-28

产品代码PEN

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决定实质等同

器械摘要

iC-GN iC-Cassette for use on the iC-System is the device name listed in this FDA 510(k) record. The listed applicant is Icubate, Inc.. It received FDA 510(k) clearance on 2019-06-28 under 510(k) number K190341. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iC-GN iC-Cassette for use on the iC-System?

iC-GN iC-Cassette for use on the iC-System is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Icubate, Inc.. The 510(k) number is K190341.

When did iC-GN iC-Cassette for use on the iC-System receive FDA 510(k) clearance?

iC-GN iC-Cassette for use on the iC-System received FDA 510(k) clearance on 2019-06-28, under 510(k) number K190341.

Who is the listed applicant for iC-GN iC-Cassette for use on the iC-System?

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

What is the FDA product code for iC-GN iC-Cassette for use on the iC-System?

The FDA product code for iC-GN iC-Cassette for use on the iC-System is PEN.

列明Icubate, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K163390iC-GPC 测定试剂盒™，适用于iC-System™

相关器械（代码：PEN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262168QIAstat-Dx BCID GN Plus 抗生素耐药性检测板QIAGEN GmbH K243013LIAISON PLEX 革兰氏阴性血培养检测Luminex Corporation K243759BIOFIRE血培养鉴定2（BCID2）面板（RFIT-ASY-0147（30包装）RFIT-ASY-0148（6包装））Biofire Diagnostics, LLC K213236ePlex 血培养鉴定革兰氏阴性（BCID-GN）试剂盒Genmark Diagnostics, Incorporated K193519BioFire 血培养鉴定 2 (BCID2) 面板Biofire Diagnostics, LLC K182619ePlex 血培养鉴定革兰氏阴性（BCID-GN）试剂盒Genmark Diagnostics, Incorporated

官方来源

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