Cleared Traditional

K850938 - CHOLESTEROL

K850938 is an FDA 510(k) clearance for CHOLESTEROL, manufactured by Dilab, Inc.. The device is a Class 1 Chemistry device with product code CGO cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K850938 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
110d
Days
Class 1
Risk

K850938 is an FDA 510(k) clearance for the CHOLESTEROL. Classified as Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol (product code CGO), Class I - General Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dilab, Inc. devices

FDA 510(k) Submission Details - K850938

510(k) Number K850938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 25, 1985
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

CGO Device Classification - Class 1, General Controls

Product Code CGO Lieberman-burchard/abell-kendall, Colorimetric, 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 - CGO Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol

All 9
Devices cleared under the same product code (CGO) and FDA review panel - the closest regulatory comparables to K850938.
KING DIAGNOSTICS CHOLESTEROL TEST
K811747 · King Diagnostics, Inc. · Jul 1981
CHOLESTEROL REAGENT
K810090 · Anco Medical Reagents & Assoc. · Jan 1981
REAGENTS FOR DETERM. CHOLESTEROL/SERUM
K800682 · Diagnostic Solutions, Inc. · May 1980
CHOLESTEROL DET. IN SERUM
K781611 · Fisher Scientific Co., LLC · Oct 1978
SR-PLUS DIRECT CHOLESTEROL TEST
K780545 · Stanbio Laboratory · May 1978
CHOLESTEROL
K771833 · Gamma Enterprises, Inc. · Oct 1977