Cleared Traditional

K832783 - MICRO-SAMPLE OSMOMETER 3M0

K832783 is an FDA 510(k) clearance for MICRO-SAMPLE OSMOMETER 3M0, manufactured by Advanced Instruments, Inc.. The device is a Class 1 Chemistry device with product code JJM cleared through the Traditional 510(k) pathway after a 104-day FDA review.

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

FDA 510(k) Submission Details - K832783

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.

JJM Device Classification - Class 1, General Controls

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.