FDA 510(k)

QUANTA Flash HMGCR 试剂

K号: K180975 · 2018-06-25

决定日期2018-06-25

产品代码LLL

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决定实质等同

器械摘要

QUANTA Flash HMGCR Reagents is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-25 under 510(k) number K180975. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QUANTA Flash HMGCR Reagents?

QUANTA Flash HMGCR Reagents is a medical device that received FDA 510(k) clearance on 2018-06-25. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K180975.

When did QUANTA Flash HMGCR Reagents receive FDA 510(k) clearance?

QUANTA Flash HMGCR Reagents received FDA 510(k) clearance on 2018-06-25, under 510(k) number K180975.

Who is the listed applicant for QUANTA Flash HMGCR Reagents?

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

What is the FDA product code for QUANTA Flash HMGCR Reagents?

The FDA product code for QUANTA Flash HMGCR Reagents is LLL.

列明Inova 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。

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官方来源

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