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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluid, Diluting, White-Cell
510(k) Number K926422
Device Name VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
Applicant
SYVA CO.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Applicant Contact PAUL L ROGERS
Correspondent
SYVA CO.
P.O. BOX 49013
SAN JOSE,  CA  95161 -9013
Correspondent Contact PAUL L ROGERS
Regulation Number864.8200
Classification Product Code
GGJ  
Date Received12/23/1992
Decision Date 06/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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