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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 K923571
Device Name VISTA TRIIODOTHYRONINE ASSAY
Applicant
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE,  CA  95135 -1500
Applicant Contact ROGERS, JR.
Correspondent
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE,  CA  95135 -1500
Correspondent Contact ROGERS, JR.
Regulation Number862.1710
Classification Product Code
CDP  
Date Received07/17/1992
Decision Date 10/15/1992
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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