FDA 510(k)

ADVIA Centaur HAV IgM Assay

K号: K161964 · 2016-10-13

决定日期2016-10-13

产品代码LOL

咨询委员会MI

决定Substantially Equivalent

器械摘要

ADVIA Centaur HAV IgM Assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) number K161964. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA Centaur HAV IgM Assay?

ADVIA Centaur HAV IgM Assay is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K161964.

When did ADVIA Centaur HAV IgM Assay receive FDA 510(k) clearance?

ADVIA Centaur HAV IgM Assay received FDA 510(k) clearance on 2016-10-13, under 510(k) number K161964.

Who is the listed applicant for ADVIA Centaur HAV IgM Assay?

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

What is the FDA product code for ADVIA Centaur HAV IgM Assay?

The FDA product code for ADVIA Centaur HAV IgM Assay is LOL.

列明Siemens Healthcare 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。

K253528Atellica IM CA 19-9 II K261364Atellica CH Acetaminophen 2 (ACTM)K251998Atellica CH Diazo Total Bilirubin (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630Atellica IM Total PSA II (tPSAII)K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)

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