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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunochemical, Thyroglobulin Autoantibody
510(k) Number K930777
Device Name THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT
Applicant
Nichols Institute
33608 Ortega Highway
San Juan Capistrano,  CA  92690
Applicant Contact SALVADORE PALOMARES
Correspondent
Nichols Institute
33608 Ortega Highway
San Juan Capistrano,  CA  92690
Correspondent Contact SALVADORE PALOMARES
Regulation Number866.5870
Classification Product Code
JNL  
Date Received02/16/1993
Decision Date 04/08/1993
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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