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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K923676
Device Name VISTA THYROXINE UPTAKE ASSAY
Applicant
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE,  CA  95135 -1500
Applicant Contact PAUL L ROGERS
Correspondent
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE,  CA  95135 -1500
Correspondent Contact PAUL L ROGERS
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received07/22/1992
Decision Date 10/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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