Cleared Traditional

MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)

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

About This 510(k) Submission

K950221 is an FDA 510(k) clearance for the MULTIPLE (IZON BLOOD & URINE COLLECTION KIT), a Kit, Screening, Urine (Class I — General Controls, product code JXA), submitted by Izon Business Products, Inc. (West Nyack, US). The FDA issued a Cleared decision on March 21, 1995, 61 days after receiving the submission on January 19, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K950221 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JXA — Kit, Screening, Urine
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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