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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resins, Ion-Exchange
510(k) Number K844948
Device Name SYVA SOLID PHASE COLUMNS
Applicant
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Applicant Contact JOAN KURJIAN
Correspondent
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Correspondent Contact JOAN KURJIAN
Regulation Number862.2230
Classification Product Code
KEA  
Date Received12/20/1984
Decision Date 08/29/1985
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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