Cleared Traditional

K800765 - CENTRIFICHEM CHOLESTEROL

K800765 is an FDA 510(k) clearance for CENTRIFICHEM CHOLESTEROL, manufactured by Union Carbide Corp.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K800765 · Union Carbide Corp. · Chemistry device
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Apr 1980
Decision
17d
Days
Class 1
Risk

K800765 is an FDA 510(k) clearance for the CENTRIFICHEM CHOLESTEROL. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 17 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K800765

510(k) Number K800765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1980
Decision Date April 24, 1980
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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 137
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K800765.
CHOLESTEROL REAGENT
K810405 · Gilford Diagnostics · Feb 1981
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
K803254 · Beckman Instruments, Inc. · Jan 1981
AMES SERA-PAK CHOLESTEROL REAGENT KIT
K802743 · Miles Laboratories, Inc. · Dec 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