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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 Elecsys 1010 Analyzer  
Document NumberK961488
Parent Document NumberK961488
Analyte NameT uptake (TU)
Analyte SpecialtyEndocrinology
ComplexityMODERATE
Effective Date05/07/1999
Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K961488
Device Name ELECSYS T-UPTAKE 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 Number862.1715
Classification Product Code
KHQ  
Subsequent Product Code
JIS  
Date Received04/18/1996
Decision Date 06/12/1996
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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