Cleared Traditional

K834208 - COLLOID OSMOMETER 4400 (FDA 510(k) Clearance)

Class I Chemistry device.

K834208 · Wescor, Inc. · Chemistry device
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Mar 1984
Decision
109d
Days
Class 1
Risk

K834208 is an FDA 510(k) clearance for the COLLOID OSMOMETER 4400. Classified as Osmometer For Clinical Use (product code JJM), Class I - General Controls.

Submitted by Wescor, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2730 - 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 Wescor, Inc. devices

Submission Details

510(k) Number K834208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1983
Decision Date March 23, 1984
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJM Osmometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2730
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.