FDA 510(k)

Elecsys 弓形虫 IgM, Elecsys 弓形虫 IgM PreciControl

K号: K162678 · 2017-06-23

决定日期2017-06-23

产品代码LGD

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决定实质等同

器械摘要

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K162678. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Roche Diagnostics. The 510(k) number is K162678.

When did Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl receive FDA 510(k) clearance?

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl received FDA 510(k) clearance on 2017-06-23, under 510(k) number K162678.

Who is the listed applicant for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?

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 Toxo IgM, Elecsys Toxo IgM PreciControl?

The FDA product code for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is LGD.

列明Roche Diagnostics为申报人的其他记录

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