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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, Opiates
510(k) Number K974840
Device Name ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Applicant Contact JAMES W HAYNES
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Correspondent Contact JAMES W HAYNES
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DJJ   DLR  
Date Received12/24/1997
Decision Date 04/24/1998
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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