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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Salicylate
510(k) Number K946000
Device Name ABUSCREEN ONLINE(R) CALIBRATORS
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Applicant Contact MARIA FEIJOO
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Correspondent Contact MARIA FEIJOO
Regulation Number862.3830
Classification Product Code
DKJ  
Date Received12/06/1994
Decision Date 01/25/1995
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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