Home / 510(k) Clearances / K180504

510(k) K180504

Mission Lipid Panel Monitoring System by ACON Laboratories, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2018
Date Received
February 26, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

Other clearances by ACON Laboratories, Inc.

  • K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test St (November 26, 2025)
  • K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test (October 22, 2025)
  • K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK (October 10, 2025)
  • K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test (May 10, 2025)
  • K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)
  • K233373 — Flowflex® Plus COVID-19 Home Test (April 19, 2024)
  • K230828 — Flowflex COVID-19 Antigen Home Test (November 9, 2023)
  • K193318 — Distinct® Early Detection Pregnancy Test (August 20, 2020)
  • K192175 — On Call Express II Blood Glucose Monitoring System (October 17, 2019)
  • K191038 — On Call Express Voice Blood Glucose Monitoring System (June 12, 2019)

Other clearances for product code CHH

  • K251091 — Lipids (December 30, 2025)
  • K232404 — CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (August 9, 2024)
  • K203597 — Cholesterol2 (June 30, 2022)
  • K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides (March 27, 2019)
  • K181373 — Extended Lipid Panel Assay (October 18, 2018)
  • K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (July 11, 2017)
  • K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test Sys (December 22, 2016)
  • K150654 — Cholesterol (September 29, 2015)
  • K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (March 21, 2014)
  • K130200 — PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (February 15, 2013)