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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 K962817
Device Name DRUG CALIBRATOR II
Applicant
Dade Intl., Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Applicant Contact CAROLYN K GEORGE
Correspondent
Dade Intl., Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.3200
Classification Product Code
DKB  
Date Received07/19/1996
Decision Date 09/16/1996
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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