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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 K954608
Device Name CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
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 Received10/04/1995
Decision Date 12/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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