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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 K911688
Device Name INNOFLUOR(TM) VALPROIC ACID REAGENT SET
Applicant
Intl. Bioclinical, Inc.
6040 N. Cutter Cir.
Suite 317
Portland,  OR  97217
Applicant Contact CRAIG SMART
Correspondent
Intl. Bioclinical, Inc.
6040 N. Cutter Cir.
Suite 317
Portland,  OR  97217
Correspondent Contact CRAIG SMART
Regulation Number862.3645
Classification Product Code
LEG  
Date Received04/16/1991
Decision Date 07/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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