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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Thyroid Autoantibody
510(k) Number K915428
Device Name KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT
Applicant
Kronus
P.O. Box 1075 Suite 312
Dana Point,  CA  92629
Applicant Contact DOERSCHUK
Correspondent
Kronus
P.O. Box 1075 Suite 312
Dana Point,  CA  92629
Correspondent Contact DOERSCHUK
Regulation Number866.5870
Classification Product Code
JZO  
Date Received12/02/1991
Decision Date 03/30/1992
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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