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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name chromatography (liquid, gel), clinical use
510(k) Number K861392
Device Name SYVA SOLID PHASE COLUMNS SYSTEM II
Original Applicant
SYVA CO.
900 arastradero rd.
p.o. box 10058
palo alto,  CA  94303
Original Contact eleanor v chiu
Regulation Number862.2260
Classification Product Code
KZR  
Date Received04/14/1986
Decision Date 06/13/1986
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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