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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K950588
Device Name T4 MICROWELL EIA (ENZYME IMMUNOASSAY0
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 Number862.1700
Classification Product Code
KLI  
Date Received02/09/1995
Decision Date 06/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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