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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K951888
Device Name DADE STRATUS TROPONIN-I CONTROL
Applicant
Dade Intl., Inc.
P.O.Box 520672
Miami,  FL  33152
Applicant Contact ALINA CARABALLO
Correspondent
Dade Intl., Inc.
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact ALINA CARABALLO
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/24/1995
Decision Date 07/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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