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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 K894364
Device Name MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
Applicant
Kronus
P.O. Box 1075 Suite 312
Dana Point,  CA  92629
Applicant Contact DOERSCHUK, PHD
Correspondent
Kronus
P.O. Box 1075 Suite 312
Dana Point,  CA  92629
Correspondent Contact DOERSCHUK, PHD
Regulation Number866.5870
Classification Product Code
JZO  
Date Received07/14/1989
Decision Date 07/25/1989
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
Recalls CDRH Recalls
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