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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameRoche Diagnostics Hitachi 914  
Document NumberK962099
Parent Document NumberK962099
Analyte NameProcainamide
Analyte SpecialtyToxicology / TDM
ComplexityMODERATE
Effective Date05/07/1999
Device Classification Name Enzyme Immunoassay, Procainamide
510(k) Number K962099
Device Name CEDIA PROCAINAMIDE ASSAY
Applicant
Boehringer Mannheim Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524
Applicant Contact MARY KONING
Correspondent
Boehringer Mannheim Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524
Correspondent Contact MARY KONING
Regulation Number862.3320
Classification Product Code
LAR  
Date Received05/29/1996
Decision Date 08/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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