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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 K964372
Device Name CARDIAC T TROPONIN T RAPID ASSAY
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact JOHN D STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact JOHN D STEVENS
Regulation Number862.1215
Classification Product Code
MMI  
Date Received11/01/1996
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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