FDA 510(k)

Maverick诊断系统TC1000；Maverick测试面板A0.B0

K号: K234091 · 2024-07-22

决定日期2024-07-22

产品代码JLW

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is the device name listed in this FDA 510(k) record. The listed applicant is Genalyte, Inc.. It received FDA 510(k) clearance on 2024-07-22 under 510(k) number K234091. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is a medical device that received FDA 510(k) clearance on 2024-07-22. The listed applicant is Genalyte, Inc.. The 510(k) number is K234091.

When did Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 receive FDA 510(k) clearance?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 received FDA 510(k) clearance on 2024-07-22, under 510(k) number K234091.

Who is the listed applicant for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

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

What is the FDA product code for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

The FDA product code for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is JLW.

列明Genalyte, 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。

K191085Maverick RNP检测和Maverick诊断系统

相关器械（代码：JLW）

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。

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官方来源

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