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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
510(k) Number K871194
Device Name I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT
Applicant
Cronus
P.O. Box 1827
Carlsbad,  CA  92008
Applicant Contact BOB COWDEN
Correspondent
Cronus
P.O. Box 1827
Carlsbad,  CA  92008
Correspondent Contact BOB COWDEN
Regulation Number866.5660
Classification Product Code
DBL  
Date Received03/24/1987
Decision Date 04/20/1987
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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