Cleared Traditional

MULTIPLE (IZON DBS & URINE COLLECTION KIT)

K950257 · Izon Business Products, Inc. · Chemistry
Apr 1995
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K950257 is an FDA 510(k) clearance for the MULTIPLE (IZON DBS & 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 April 14, 1995, 81 days after receiving the submission on January 23, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K950257 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1995
Decision Date April 14, 1995
Days to Decision 81 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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