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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K932548
Device Name ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Applicant Contact MARIA FEIJOO
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Correspondent Contact MARIA FEIJOO
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received05/26/1993
Decision Date 12/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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