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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 Mixture
510(k) Number K935550
Device Name ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
Applicant
Roche Diagnostic Systems, Inc.
1080 U.S. Highway 202
Branchburg,  NJ  08876 -1760
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
1080 U.S. Highway 202
Branchburg,  NJ  08876 -1760
Correspondent Contact CAROL L KRIEGER
Regulation Number862.3200
Classification Product Code
DKB  
Date Received11/17/1993
Decision Date 01/03/1994
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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