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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thyroglobulin, Antigen, Antiserum, Control
510(k) Number K936010
Device Name THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
Applicant
Biomerica, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact PERRY G RUCKER
Correspondent
Biomerica, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact PERRY G RUCKER
Regulation Number866.5870
Classification Product Code
DDC  
Date Received12/16/1993
Decision Date 07/18/1994
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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