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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, Phencyclidine
510(k) Number K964355
Device Name ONTRAK TESTCUP 5 (MODIFICATION)
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Applicant Contact ALEX WESOLOWSKI
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Correspondent Contact ALEX WESOLOWSKI
Classification Product Code
LCM  
Date Received11/01/1996
Decision Date 12/13/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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