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510(k) K181373

Extended Lipid Panel Assay by Laboratory Corporation of America Holdings — Product Code CHH

K181373 is an FDA 510(k) premarket notification submitted by Laboratory Corporation of America Holdings for the device "Extended Lipid Panel Assay". The FDA issued a decision of Substantially Equivalent on October 18, 2018. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2018
Date Received
May 24, 2018
Clearance Type
Traditional
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 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)
  • K180504 — Mission Lipid Panel Monitoring System (March 28, 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)

FDA data resources