Cleared Traditional

MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (K950221) - FDA 510(k) Clearance

Class I Chemistry device.

K950221 · Izon Business Products, Inc. · Chemistry device
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Mar 1995
Decision
61d
Days
Class 1
Risk

K950221 is an FDA 510(k) clearance for the MULTIPLE (IZON BLOOD & URINE COLLECTION KIT). Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Izon Business Products, Inc. (West Nyack, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Izon Business Products, Inc. devices

Submission Details

510(k) Number K950221 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 19, 1995
Decision Date March 21, 1995
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.