Cleared Traditional

K831389 - STAT-TRAK LIQUID ELECTROLYTE CONTROL

K831389 is an FDA 510(k) clearance for STAT-TRAK LIQUID ELECTROLYTE CONTROL, manufactured by United Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJR cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K831389 · United Diagnostics, Inc. · Chemistry device
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Aug 1983
Decision
103d
Days
Class 1
Risk

K831389 is an FDA 510(k) clearance for the STAT-TRAK LIQUID ELECTROLYTE CONTROL. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by United Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1983 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 United Diagnostics, Inc. devices

FDA 510(k) Submission Details - K831389

510(k) Number K831389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1983
Decision Date August 10, 1983
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

JJR Device Classification - Class 1, General Controls

Product Code JJR Electrolyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.