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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K910261
Device Name IMMULITE(TM) TOTAL T4
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 Number862.1700
Classification Product Code
KLI  
Date Received01/22/1991
Decision Date 04/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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