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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 K964715
Device Name PARAMAX SALICYLATE REAGENT
Applicant
Dade Intl., Inc.
9750 NW 25th St.
Miami,  FL  33172
Applicant Contact MARIAN HARDING COCHRAN
Correspondent
Dade Intl., Inc.
9750 NW 25th St.
Miami,  FL  33172
Correspondent Contact MARIAN HARDING COCHRAN
Regulation Number862.3830
Classification Product Code
DKJ  
Date Received11/25/1996
Decision Date 04/25/1997
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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