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FDA 510(k)

Mission Lipid Panel Monitoring System

K-Number: K180504 · 2018-03-28

ApplicantACON Laboratories, Inc.
Decision Date2018-03-28
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Mission Lipid Panel 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 2018-03-28 under 510(k) number K180504. 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 Lipid Panel Monitoring System?

Mission Lipid Panel Monitoring System is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K180504.

When did Mission Lipid Panel Monitoring System receive FDA 510(k) clearance?

Mission Lipid Panel Monitoring System received FDA 510(k) clearance on 2018-03-28, under 510(k) number K180504.

Who is the listed applicant for Mission Lipid Panel 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 Lipid Panel Monitoring System?

The FDA product code for Mission Lipid Panel Monitoring System is CHH.

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Related Devices (Code: CHH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.

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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