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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K982954
Device Name FREE T4 MICROWELL EIA, MODEL #7019
Applicant
BIOMERICA, INC.
1533 MONROVIA AVE.
NEWPORT BEACH,  CA  92663
Applicant Contact JAY SINGH
Correspondent
BIOMERICA, INC.
1533 MONROVIA AVE.
NEWPORT BEACH,  CA  92663
Correspondent Contact JAY SINGH
Regulation Number862.1695
Classification Product Code
CEC  
Date Received08/24/1998
Decision Date 09/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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