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FDA 510(k)

QUANTA Flash Scl-70，QUANTA Flash Scl-70 校准器，QUANTA Flash Scl-70 控制品

K号: K152635 · 2016-06-01

申请人Inova Diagnostics, Inc.
决定日期2016-06-01
产品代码LLL
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决定实质等同

器械摘要

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 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 2016-06-01 under 510(k) number K152635. 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 Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls?

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls is a medical device that received FDA 510(k) clearance on 2016-06-01. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K152635.

When did QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls receive FDA 510(k) clearance?

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls received FDA 510(k) clearance on 2016-06-01, under 510(k) number K152635.

Who is the listed applicant for QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 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 Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls?

The FDA product code for QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls is LLL.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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

查看所有 16 个设备 →

相关器械（代码：LLL）

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。

K253817IDS SS-A/Ro；IDS SS-A/Ro 60 kDa；IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 屏幕检测Phadia ABK250666Alegria Flash CTD屏幕Zeus ScientificK250408Alegria Flash ENA屏幕Zeus ScientificK213403Aptiva CTD 基础试剂Inova Diagnostics, Inc.K190710EliA SymphonyS 免疫测定Phadia AB

官方来源

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