Cleared Traditional

CHOLESTEROL (K850938) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

Device Classification

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.