Cleared Traditional

K844589 - OSMOLARITY STANDARDS (FDA 510(k) Clearance)

Class I Chemistry device.

K844589 · Rna Medical Corp. · Chemistry device
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Mar 1985
Decision
95d
Days
Class 1
Risk

K844589 is an FDA 510(k) clearance for the OSMOLARITY STANDARDS. Classified as Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality (product code JMZ), Class I - General Controls.

Submitted by Rna Medical Corp. (Woburn, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1540 - 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 Rna Medical Corp. devices

Submission Details

510(k) Number K844589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1984
Decision Date March 01, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JMZ Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1540
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.