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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, total triiodothyronine
510(k) Number K904098
Device Name CEDIA TOTAL T3 ASSAY
Applicant
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Applicant Contact Patricia M Klimley
Correspondent
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Correspondent Contact Patricia M Klimley
Regulation Number862.1710
Classification Product Code
CDP  
Date Received09/06/1990
Decision Date 09/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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