FDA 510(k)

Elecsys Anti-HCV II (08837031190)

K号: K221693 · 2023-01-04

决定日期2023-01-04

产品代码MZO

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决定实质等同

器械摘要

Elecsys Anti-HCV II (08837031190) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K221693. The device is classified under product code MZO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys Anti-HCV II (08837031190)?

Elecsys Anti-HCV II (08837031190) is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Roche Diagnostics. The 510(k) number is K221693.

When did Elecsys Anti-HCV II (08837031190) receive FDA 510(k) clearance?

Elecsys Anti-HCV II (08837031190) received FDA 510(k) clearance on 2023-01-04, under 510(k) number K221693.

Who is the listed applicant for Elecsys Anti-HCV II (08837031190)?

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 Anti-HCV II (08837031190)?

The FDA product code for Elecsys Anti-HCV II (08837031190) is MZO.

列明Roche Diagnostics为申报人的其他记录

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