Cleared Traditional

CHOLESTEROL (CHOL) TEST ITEM NO. 65410

K935136 · Em Diagnostic Systems, Inc. · Chemistry
Dec 1993
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K935136 is an FDA 510(k) clearance for the CHOLESTEROL (CHOL) TEST ITEM NO. 65410, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 16, 1993, 49 days after receiving the submission on October 28, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K935136 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1993
Decision Date December 16, 1993
Days to Decision 49 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