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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Antigen, Antiserum, Control
510(k) Number K831103
Device Name TIA-IGM REAGENT & CALIBRATOR SETS
Applicant
Worthington Diagnostic Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Worthington Diagnostic Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5550
Classification Product Code
DFT  
Date Received04/05/1983
Decision Date 04/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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