FDA 510(k)

ADVIA Centaur 总IgE (tIgE)

K号: K193493 · 2020-01-15

决定日期2020-01-15

产品代码DGC

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决定实质等同

器械摘要

ADVIA Centaur Total IgE (tIgE) 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 2020-01-15 under 510(k) number K193493. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA Centaur Total IgE (tIgE)?

ADVIA Centaur Total IgE (tIgE) is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K193493.

When did ADVIA Centaur Total IgE (tIgE) receive FDA 510(k) clearance?

ADVIA Centaur Total IgE (tIgE) received FDA 510(k) clearance on 2020-01-15, under 510(k) number K193493.

Who is the listed applicant for ADVIA Centaur Total IgE (tIgE)?

FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for ADVIA Centaur Total IgE (tIgE)?

The FDA product code for ADVIA Centaur Total IgE (tIgE) is DGC.

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 对乙酰氨基酚 2 (ACTM)K251998Atellica CH 碘化物总胆红素 (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630Atellica IM 总PSA II (tPSAII)K250816ADVIA Centaur 抗甲状腺球蛋白II (aTgII)

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