FDA 510(k)

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System

Número K: K163406 · 2017-07-11

Data da decisão2017-07-11

Código do produtoCHH

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K163406. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K163406.

When did Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System receive FDA 510(k) clearance?

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System received FDA 510(k) clearance on 2017-07-11, under 510(k) number K163406.

Who is the listed applicant for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

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

What is the FDA product code for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

The FDA product code for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is CHH.

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Fonte oficial

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