ARK 拉考沙胺测定法
K号: K201089 · 2021-08-05
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决定日期2021-08-05
产品代码NWM
咨询委员会TX
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决定实质等同
器械摘要
ARK Lacosamide Assay is the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K201089. The device is classified under product code NWM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ARK Lacosamide Assay?
ARK Lacosamide Assay is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K201089.
When did ARK Lacosamide Assay receive FDA 510(k) clearance?
ARK Lacosamide Assay received FDA 510(k) clearance on 2021-08-05, under 510(k) number K201089.
Who is the listed applicant for ARK Lacosamide Assay?
The FDA 510(k) record lists Ark Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ARK Lacosamide Assay?
The FDA product code for ARK Lacosamide Assay is NWM.
相关临床试验
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。
列明Ark Diagnostics, 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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