Cleared Traditional

TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL

K946063 · Cholestech Corp. · Chemistry
Feb 1995
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K946063 is an FDA 510(k) clearance for the TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on February 22, 1995, 99 days after receiving the submission on November 15, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K946063 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1994
Decision Date February 22, 1995
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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