FDA 510(k)

ADVIA Centaur 抗甲状腺球蛋白II (aTgII)

K号: K250816 · 2025-12-04

决定日期2025-12-04

产品代码JNL

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决定实质等同

器械摘要

ADVIA Centaur Anti-Thyroglobulin II (aTgII) 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 2025-12-04 under 510(k) number K250816. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA Centaur Anti-Thyroglobulin II (aTgII)?

ADVIA Centaur Anti-Thyroglobulin II (aTgII) is a medical device that received FDA 510(k) clearance on 2025-12-04. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K250816.

When did ADVIA Centaur Anti-Thyroglobulin II (aTgII) receive FDA 510(k) clearance?

ADVIA Centaur Anti-Thyroglobulin II (aTgII) received FDA 510(k) clearance on 2025-12-04, under 510(k) number K250816.

Who is the listed applicant for ADVIA Centaur Anti-Thyroglobulin II (aTgII)?

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 Anti-Thyroglobulin II (aTgII)?

The FDA product code for ADVIA Centaur Anti-Thyroglobulin II (aTgII) is JNL.

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)K250250ADVIA Centaur 抗甲状腺过氧化物酶II

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