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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 cobas c 311 Analyzer  
Document NumberK961824
Parent Document NumberK961824
Analyte NameDigoxin
Analyte SpecialtyToxicology / TDM
ComplexityMODERATE
Effective Date04/06/2009
Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K961824
Device Name COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Applicant Contact MARIA FEIJOO
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Correspondent Contact MARIA FEIJOO
Regulation Number866.5040
Classification Product Code
DCF  
Subsequent Product Codes
KXT   LCP  
Date Received05/10/1996
Decision Date 07/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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