EPISCREEN

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

EPITOPE, INC.

The following data is part of a premarket notification filed by Epitope, Inc. with the FDA for Episcreen.

Pre-market Notification Details

• Device ID: K970357
• 510k Number: K970357
• Device Name: EPISCREEN
• Classification: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
• Applicant: EPITOPE, INC. 8505 S.W. CREEKSIDE PLACE Beaverton, OR 97008
• Contact: Caroline R Sayre, Rac
• Correspondent: Caroline R Sayre, Rac; EPITOPE, INC. 8505 S.W. CREEKSIDE PLACE Beaverton, OR 97008
• Product Code: PJD
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-01-30
• Decision Date: 1997-03-10
• Summary: summary