Cleared Traditional

EPISCREEN

K970357 · Epitope, Inc. · Microbiology

Mar 1997

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K970357 is an FDA 510(k) clearance for the EPISCREEN, 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 March 10, 1997, 39 days after receiving the submission on January 30, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K970357 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1997
Decision Date	March 10, 1997
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
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.