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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 K963191
Device Name CEDIA ANTIBIOTIC TDM MULTI-CALS
Applicant
Boehringer Mannheim Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524 -4117
Applicant Contact BETSY SOARES-MADDOX
Correspondent
Boehringer Mannheim Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524 -4117
Correspondent Contact BETSY SOARES-MADDOX
Regulation Number862.3200
Classification Product Code
DKB  
Date Received08/15/1996
Decision Date 09/10/1996
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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