Cleared Traditional

EPISCREEN ORAL SPECIMEN COLLECTION DEVICE

K973395 · Epitope, Inc. · Chemistry

Feb 1998

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K973395 is an FDA 510(k) clearance for the EPISCREEN ORAL SPECIMEN COLLECTION DEVICE, a Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (Class II — Special Controls, product code PJD), submitted by Epitope, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 13, 1998, 176 days after receiving the submission on August 21, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K973395 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 1997
Decision Date	February 13, 1998
Days to Decision	176 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.