Cleared Traditional

ORAL-EZE ORAL FLUID COLLECTION SYSTEM

K984361 · Osborn Laboratories, Inc. · Chemistry

Jan 1999

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K984361 is an FDA 510(k) clearance for the ORAL-EZE ORAL FLUID COLLECTION SYSTEM, a Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (Class II — Special Controls, product code PJD), submitted by Osborn Laboratories, Inc. (Olathe, US). The FDA issued a Cleared decision on January 13, 1999, 37 days after receiving the submission on December 7, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K984361 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 1998
Decision Date	January 13, 1999
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PJD — Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1675
Definition	Intended For Use In The Collection, Preservation, And Transport Of Oral Fluid Specimens For Drugs Of Abuse Or Alcohol Testing.