Cleared Traditional

K834505 - HUMAN SERUM ELECTROLYTE CONTROL-LIQUID (FDA 510(k) Clearance)

Class I Chemistry device.

K834505 · Quantimetrix Corp. · Chemistry device
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Apr 1984
Decision
114d
Days
Class 1
Risk

K834505 is an FDA 510(k) clearance for the HUMAN SERUM ELECTROLYTE CONTROL-LIQUID. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Quantimetrix Corp. (Walker, US). The FDA issued a Cleared decision on April 13, 1984 after a review of 114 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 Quantimetrix Corp. devices

Submission Details

510(k) Number K834505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date April 13, 1984
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 88d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.