Cleared Traditional

SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD

K864159 · Chem-Elec, Inc. · Chemistry
Jun 1988
Decision
596d
Days
Class 1
Risk

About This 510(k) Submission

K864159 is an FDA 510(k) clearance for the SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Chem-Elec, Inc. (North Webster, US). The FDA issued a Cleared decision on June 10, 1988, 596 days after receiving the submission on October 23, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K864159 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1986
Decision Date June 10, 1988
Days to Decision 596 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