FDA 510(k)

QUANTA Flash dsDNA，QUANTA Flash dsDNA 校准器，和 QUANTA Flash dsDNA 控制品

K号: K152013 · 2016-04-11

决定日期2016-04-11

产品代码LSW

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决定实质等同

器械摘要

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls 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 2016-04-11 under 510(k) number K152013. The device is classified under product code LSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls?

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K152013.

When did QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls receive FDA 510(k) clearance?

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls received FDA 510(k) clearance on 2016-04-11, under 510(k) number K152013.

Who is the listed applicant for QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls?

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 dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls?

The FDA product code for QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls is LSW.

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。

K243979Aptiva APS IgA 试剂 K223093Aptiva APS IgG 试剂; Aptiva APS IgM 试剂 K213403Aptiva CTD 基础试剂 K200230Aptiva 慢性炎症性肠病 IgG 试剂 K193604Aptiva 慢性炎症性肠病 IgA 试剂 K192916NOVA Lite DAPI dsDNA Crithidia luciliae试剂盒

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官方来源

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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。