Cleared Traditional

K832783 - MICRO-SAMPLE OSMOMETER 3M0 (FDA 510(k) Clearance)

Class I Chemistry device.

K832783 · Advanced Instruments, Inc. · Chemistry device
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Nov 1983
Decision
104d
Days
Class 1
Risk

K832783 is an FDA 510(k) clearance for the MICRO-SAMPLE OSMOMETER 3M0. Classified as Osmometer For Clinical Use (product code JJM), Class I - General Controls.

Submitted by Advanced Instruments, Inc.. The FDA issued a Cleared decision on November 28, 1983 after a review of 104 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 Advanced Instruments, Inc. devices

Submission Details

510(k) Number K832783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date November 28, 1983
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
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.