Maverick RNP检测和Maverick诊断系统
K号: K191085 · 2019-10-25
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决定日期2019-10-25
产品代码LKO
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器械摘要
Maverick RNP Assay and Maverick Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Genalyte, Inc.. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191085. The device is classified under product code LKO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Maverick RNP Assay and Maverick Diagnostic System?
Maverick RNP Assay and Maverick Diagnostic System is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Genalyte, Inc.. The 510(k) number is K191085.
When did Maverick RNP Assay and Maverick Diagnostic System receive FDA 510(k) clearance?
Maverick RNP Assay and Maverick Diagnostic System received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191085.
Who is the listed applicant for Maverick RNP Assay and Maverick Diagnostic System?
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 RNP Assay and Maverick Diagnostic System?
The FDA product code for Maverick RNP Assay and Maverick Diagnostic System is LKO.
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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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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