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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Barbiturate
510(k) Number K983698
Device Name MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Applicant Contact RITA SMITH
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Correspondent Contact RITA SMITH
Regulation Number862.3150
Classification Product Code
DIS  
Date Received10/21/1998
Decision Date 05/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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