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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 K931311
Device Name THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT
Applicant
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Applicant Contact SALVADORE PALOMARES
Correspondent
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Correspondent Contact SALVADORE PALOMARES
Regulation Number866.5870
Classification Product Code
JZO  
Date Received03/15/1993
Decision Date 05/14/1993
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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