FDA 510(k)

Elecsys HSV-1 IgG (08948844160)

K号: K220923 · 2022-10-12

决定日期2022-10-12

产品代码MXJ

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决定实质等同

器械摘要

Elecsys HSV-1 IgG (08948844160) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K220923. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys HSV-1 IgG (08948844160)?

Elecsys HSV-1 IgG (08948844160) is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Roche Diagnostics. The 510(k) number is K220923.

When did Elecsys HSV-1 IgG (08948844160) receive FDA 510(k) clearance?

Elecsys HSV-1 IgG (08948844160) received FDA 510(k) clearance on 2022-10-12, under 510(k) number K220923.

Who is the listed applicant for Elecsys HSV-1 IgG (08948844160)?

FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Elecsys HSV-1 IgG (08948844160)?

The FDA product code for Elecsys HSV-1 IgG (08948844160) is MXJ.

列明Roche Diagnostics为申报人的其他记录

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