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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 K905214
Device Name IMMULITE (TM) TOTAL T3
Applicant
CIRRUS DIAGNOSTICS, INC.
P.O. BOX 15
CHESTER,  NJ  07930
Applicant Contact ROBERT FENNELL
Correspondent
CIRRUS DIAGNOSTICS, INC.
P.O. BOX 15
CHESTER,  NJ  07930
Correspondent Contact ROBERT FENNELL
Regulation Number862.1710
Classification Product Code
CDP  
Date Received11/20/1990
Decision Date 02/01/1991
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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