Cleared Traditional

K864729 - NEUROCHEMICAL ANALYZER

K864729 is an FDA 510(k) clearance for NEUROCHEMICAL ANALYZER, manufactured by Esa, Inc.. The device is a Class 1 Chemistry device with product code LEQ cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K864729 · Esa, Inc. · Chemistry device
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Apr 1987
Decision
130d
Days
Class 1
Risk

K864729 is an FDA 510(k) clearance for the NEUROCHEMICAL ANALYZER. Classified as Detectors, Electrochemical, Liquid Chromatography (product code LEQ), Class I - General Controls.

Submitted by Esa, Inc. (Bedford, US). The FDA issued a Cleared decision on April 13, 1987 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2260 - 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 Esa, Inc. devices

FDA 510(k) Submission Details - K864729

510(k) Number K864729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1986
Decision Date April 13, 1987
Days to Decision 130 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 88d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

LEQ Device Classification - Class 1, General Controls

Product Code LEQ Detectors, Electrochemical, Liquid Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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.