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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameOlympus AU3000i Immunoassay System  
Document NumberK062581
Parent Document NumberK062581
Analyte NameThyroid stimulating hormone (TSH)
Analyte SpecialtyEndocrinology
ComplexityMODERATE
Effective Date12/01/2006
Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K062581
Device Name OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
Applicant
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063
Applicant Contact DAVID DAVIS
Correspondent
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063
Correspondent Contact DAVID DAVIS
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Codes
JIS   JJE   JJX  
Date Received08/31/2006
Decision Date 11/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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