FDA 510(k)

LIAISON 疟原虫总抗体加，LIAISON 疟原虫总抗体加控制套件

K号: K193051 · 2020-01-29

决定日期2020-01-29

产品代码LSR

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决定实质等同

器械摘要

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K193051. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is DiaSorin, Inc.. The 510(k) number is K193051.

When did LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set receive FDA 510(k) clearance?

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set received FDA 510(k) clearance on 2020-01-29, under 510(k) number K193051.

Who is the listed applicant for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

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

What is the FDA product code for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

The FDA product code for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is LSR.

列明DiaSorin, 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。

K260770LIAISON Murex HBsAg Qual；LIAISON XL；LIAISON 稀释X K231214LIAISON VZV IgG HT，LIAISON 控制VZV IgG HT K223403LIAISON Anti-HAV; LIAISON XS K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus K213936LIAISON MeMed BV，LIAISON MeMed BV控制套件 K193650LIAISON Ferritin

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相关器械（代码：LSR）

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。

K254295Sofia Lyme FIA；Sofia 2 螺旋菌 FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG 测试；Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart莱姆病IgG免疫印迹试剂盒Id-Fish Technology, Inc.K230863宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM对照试剂盒Zeus Scientific K220016Viramed Borrela 全合一 ViraChip 检测试剂盒Viramed Biotech AG

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。