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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Valproic Acid
510(k) Number K011947
Device Name EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
Applicant
Syva Co.
20400 Mariani Ave.
Cupertino,  CA  95014
Applicant Contact SUSAN L COLLINS
Correspondent
Syva Co.
20400 Mariani Ave.
Cupertino,  CA  95014
Correspondent Contact SUSAN L COLLINS
Regulation Number862.3645
Classification Product Code
LEG  
Date Received06/21/2001
Decision Date 07/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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