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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K934121
Device Name VISTA FOLATE ASSAY
Applicant
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Applicant Contact PAUL ROGERS
Correspondent
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Correspondent Contact PAUL ROGERS
Regulation Number862.1295
Classification Product Code
CGN  
Date Received08/25/1993
Decision Date 10/22/1993
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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