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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 K961500
Device Name ELECSYS TROPONIN T
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact RICHARD NAPLES
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact RICHARD NAPLES
Regulation Number862.1215
Classification Product Code
MMI  
Date Received04/18/1996
Decision Date 06/11/1996
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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