Cleared Traditional

K780173 - LYPOPROTEIN CHOLESTEROL TEST KIT

K780173 is the FDA 510(k) clearance for LYPOPROTEIN CHOLESTEROL TEST KIT by Environmental Chemical Specialties. It is a Class 1 Chemistry device (product code JHM) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K780173 · Environmental Chemical Specialties · Chemistry device
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May 1978
Decision
90d
Days
Class 1
Risk

K780173 is an FDA 510(k) clearance for the LYPOPROTEIN CHOLESTEROL TEST KIT. Classified as Colorimetric Method, Lipoproteins (product code JHM), Class I - General Controls.

Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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.

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Submission Details

510(k) Number K780173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1978
Decision Date May 03, 1978
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHM Colorimetric Method, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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.