Cleared Traditional

K844589 - OSMOLARITY STANDARDS

K844589 is an FDA 510(k) clearance for OSMOLARITY STANDARDS, manufactured by Rna Medical Corp.. The device is a Class 1 Chemistry device with product code JMZ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K844589 · Rna Medical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K844589

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.

JMZ Device Classification - Class 1, General Controls

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.