Cleared Traditional

MULTIPLE (IZON URINE COLLECTION KIT)

K950246 · Izon Business Products, Inc. · Chemistry
Mar 1995
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K950246 is an FDA 510(k) clearance for the MULTIPLE (IZON 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, 60 days after receiving the submission on January 20, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K950246 FDA.gov
FDA Decision Cleared SESK
Date Received January 20, 1995
Decision Date March 21, 1995
Days to Decision 60 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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