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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
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
P.O. Box 49013
San Jose,  CA  95161
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
Predetermined Change
Control Plan Authorized		 No
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