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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K964862
Device Name TROPONIN-I TEST SYSTEM
Applicant
Dade Intl., Inc.
2173 NW 99th Ave.
Miami,  FL  33172
Applicant Contact RADHA GOOLABSINGH
Correspondent
Dade Intl., Inc.
2173 NW 99th Ave.
Miami,  FL  33172
Correspondent Contact RADHA GOOLABSINGH
Regulation Number862.1215
Classification Product Code
MMI  
Date Received12/04/1996
Decision Date 02/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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