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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K960412
Device Name T-3 MICROWELL EIA MODEL 7013
Applicant
Biomerica, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact JOSEPH IRANI
Correspondent
Biomerica, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact JOSEPH IRANI
Regulation Number862.1710
Classification Product Code
CDP  
Date Received01/29/1996
Decision Date 03/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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