Cleared Traditional

K800199 - LINEAR ENZYMATIC CHOLESTEROL SYSTEM

K800199 is the FDA 510(k) clearance for LINEAR ENZYMATIC CHOLESTEROL SYSTEM by Simmler, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K800199 · Simmler, Inc. · Chemistry device
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Feb 1980
Decision
22d
Days
Class 1
Risk

K800199 is an FDA 510(k) clearance for the LINEAR ENZYMATIC CHOLESTEROL SYSTEM. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Simmler, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1980 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Simmler, Inc. devices

Submission Details

510(k) Number K800199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1980
Decision Date February 21, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHH Enzymatic Esterase--oxidase, Cholesterol

All 129
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K800199.
AMES SERA-PAK CHOLESTEROL REAGENT KIT
K802743 · Miles Laboratories, Inc. · Dec 1980
CENTRIFICHEM CHOLESTEROL
K800765 · Union Carbide Corp. · Apr 1980
LIQUID-STAT LIQUID REAGENT
K800457 · Beckman Instruments, Inc. · Mar 1980
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
K792509 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1980
CHEM-STRATE CHOLESTEROL
K792478 · General Diagnostics · Dec 1979
ENZYMATIC DETERMINATION
K790724 · Sigma Chemical Co. · May 1979