Cleared Traditional

K893479 - CHOLESTEROL REAGENT SET

K893479 is the FDA 510(k) clearance for CHOLESTEROL REAGENT SET by American Monitor Corp.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K893479 · American Monitor Corp. · Chemistry device
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Jun 1989
Decision
46d
Days
Class 1
Risk

K893479 is an FDA 510(k) clearance for the CHOLESTEROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 19, 1989 after a review of 46 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 American Monitor Corp. devices

Submission Details

510(k) Number K893479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date June 19, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 126
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K893479.
COBAS READY CHOLESTEROL REAGENT
K896239 · Roche Diagnostic Systems, Inc. · Feb 1990
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · Abbott Laboratories · Oct 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · Em Diagnostic Systems, Inc. · Aug 1989
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922 · American Research Products Co. · Jun 1989
CLA 200 CHEMPRO(R) LIPID ANALYZER
K892238 · Johnson & Johnson Professionals, Inc. · Jun 1989
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
K890990 · Hichem Diagnostics · Apr 1989