FDA 510(k)

Atellica® CH 苯环己哌啶 (Pcp), Atellica® CH 万古霉素 (Vanc)

K号: K222439 · 2023-08-08

决定日期2023-08-08

产品代码LEH

咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) 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 2023-08-08 under 510(k) number K222439. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)?

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) is a medical device that received FDA 510(k) clearance on 2023-08-08. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K222439.

When did Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) receive FDA 510(k) clearance?

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) received FDA 510(k) clearance on 2023-08-08, under 510(k) number K222439.

Who is the listed applicant for Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)?

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 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)?

The FDA product code for Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) is LEH.

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)

查看所有 64 个设备 →

官方来源

在 FDA 数据库中查看 →

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。