Cleared Traditional

NEUROCHEMICAL ANALYZER (K864729) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

Device Classification

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.