Cleared Traditional

URI-VAL (K843680) - FDA 510(k) Clearance

Class I Chemistry device.

K843680 · Cenogenics Corp. · Chemistry device
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Mar 1985
Decision
192d
Days
Class 1
Risk

K843680 is an FDA 510(k) clearance for the URI-VAL. Classified as Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality (product code JMZ), Class I - General Controls.

Submitted by Cenogenics Corp. (Morganville, US). The FDA issued a Cleared decision on March 29, 1985 after a review of 192 days - an extended review cycle.

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 Cenogenics Corp. devices

Submission Details

510(k) Number K843680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1984
Decision Date March 29, 1985
Days to Decision 192 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 88d · This submission: 192d
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.