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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 K011057
Device Name INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
Applicant
OraSure Technologies, Inc.
150 Webster St.
Bethlehem,  PA  18015
Applicant Contact R.SAM NIEDBALA
Correspondent
OraSure Technologies, Inc.
150 Webster St.
Bethlehem,  PA  18015
Correspondent Contact R.SAM NIEDBALA
Regulation Number862.1675
Classification Product Code
PJD  
Date Received04/06/2001
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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