Cleared Traditional

IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL

K854179 · Clinical Data, Inc. · Chemistry
Nov 1985
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K854179 is an FDA 510(k) clearance for the IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on November 25, 1985, 41 days after receiving the submission on October 15, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K854179 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1985
Decision Date November 25, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

Similar Devices — CHH Enzymatic Esterase--oxidase, Cholesterol

All 229
Lipids
K251091 · Truvian Health · Dec 2025
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
K232404 · Medicon Hellas S.A · Aug 2024
Cholesterol2
K203597 · Abbott Ireland Diagnostics Division · Jun 2022
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · Ortho-Clinical Diagnostics, Inc. · Mar 2019
Extended Lipid Panel Assay
K181373 · Laboratory Corporation of America Holdings · Oct 2018
Mission Lipid Panel Monitoring System
K180504 · ACON Laboratories, Inc. · Mar 2018