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FDA 510(k)

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System

K-Number: K163406 · 2017-07-11

ApplicantACON Laboratories, Inc.
Decision Date2017-07-11
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by ACON Laboratories, Inc.. The 510(k) number is K163406.

When was Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System approved by the FDA?

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

What company makes Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System?

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System is manufactured by ACON Laboratories, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

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Other Devices by ACON Laboratories, Inc.

K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System K180504Mission Lipid Panel Monitoring System K180196On Call Express Mobile Blood Glucose Monitoring System K192175On Call Express II Blood Glucose Monitoring System K191038On Call Express Voice Blood Glucose Monitoring System

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Related Devices (Code: CHH)

K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemPolymer Technology Systems, Inc. K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings K180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc. K190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc. K203597Cholesterol2Abbott Ireland Diagnostics Division K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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