FDA 510(k)

cobas流感A/B & RSV核酸检测，适用于cobas Liat系统

K号: K153544 · 2016-07-25

决定日期2016-07-25

产品代码OCC

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决定实质等同

器械摘要

cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System is the device name listed in this FDA 510(k) record. The listed applicant is Iquum, Inc.. It received FDA 510(k) clearance on 2016-07-25 under 510(k) number K153544. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System?

cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Iquum, Inc.. The 510(k) number is K153544.

When did cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System receive FDA 510(k) clearance?

cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System received FDA 510(k) clearance on 2016-07-25, under 510(k) number K153544.

Who is the listed applicant for cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System?

The FDA 510(k) record lists Iquum, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System?

The FDA product code for cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System is OCC.

官方来源

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cobas流感A/B & RSV核酸检测，适用于cobas Liat系统

器械摘要

常见问题

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官方来源