FDA 510(k)

AESKUSLIDES ANA HEp-2-Gamma, HELIOS ȫԶIFAϵͳ

K号: K153117 · 2016-07-28

决定日期2016-07-28

产品代码DHN

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决定实质等同

器械摘要

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesku Systems GmbH&Co.Kg. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K153117. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM?

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Aesku Systems GmbH&Co.Kg. The 510(k) number is K153117.

When did AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM receive FDA 510(k) clearance?

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM received FDA 510(k) clearance on 2016-07-28, under 510(k) number K153117.

Who is the listed applicant for AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM?

The FDA 510(k) record lists Aesku Systems GmbH&Co.Kg as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM?

The FDA product code for AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM is DHN.

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AESKUSLIDES ANA HEp-2-Gamma, HELIOS ȫԶIFAϵͳ

器械摘要

常见问题

相关临床试验

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官方来源