Cleared Traditional

K843680 - URI-VAL

K843680 is an FDA 510(k) clearance for URI-VAL, manufactured by Cenogenics Corp.. The device is a Class 1 Chemistry device with product code JMZ cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K843680 · Cenogenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K843680

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.

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.