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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
510(k) Number K970357
Device Name EPISCREEN
Applicant
Epitope, Inc.
8505 SW Creekside Pl.
Beaverton,  OR  97008
Applicant Contact CAROLINE R SAYRE, RAC
Correspondent
Epitope, Inc.
8505 SW Creekside Pl.
Beaverton,  OR  97008
Correspondent Contact CAROLINE R SAYRE, RAC
Regulation Number862.1675
Classification Product Code
PJD  
Date Received01/30/1997
Decision Date 03/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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