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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameBoehringer Mannheim CARDIAC T Rapid Assay  
Document NumberK952478
Parent Document NumberK952478
Analyte NameTroponin T, cardiac (CTnT)
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date11/24/1995
Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K952478
Device Name BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Applicant Contact JOHN D STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Correspondent Contact JOHN D STEVENS
Regulation Number862.1215
Classification Product Code
MMI  
Date Received05/30/1995
Decision Date 11/09/1995
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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