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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 K971835
Device Name ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
Applicant
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Applicant Contact FREDERICK R JEROME
Correspondent
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Correspondent Contact FREDERICK R JEROME
Regulation Number866.5870
Classification Product Code
DDC  
Date Received05/19/1997
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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