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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 thyroxine
510(k) Number K854798
Device Name T-4 RIASSAY
Applicant
RIA DIAGNOSTICS
8226 ALLPORT AVENEUE
SANTA FE SPRINGS,  CA  90670
Applicant Contact BROUSSALIAN, PH.D
Correspondent
RIA DIAGNOSTICS
8226 ALLPORT AVENEUE
SANTA FE SPRINGS,  CA  90670
Correspondent Contact BROUSSALIAN, PH.D
Regulation Number862.1700
Classification Product Code
CDX  
Date Received12/02/1985
Decision Date 01/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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