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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 K955868
Device Name BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Applicant Contact JOHN D STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Correspondent Contact JOHN D STEVENS
Regulation Number862.1215
Classification Product Code
MMI  
Date Received12/28/1995
Decision Date 02/14/1996
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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