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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K926394
Device Name VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) 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 Number862.1485
Classification Product Code
CEP  
Date Received12/21/1992
Decision Date 05/26/1993
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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