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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 K895569
Device Name VALPROIC ACID (FPIA) KIT
Applicant
Tudor Laboratories, Inc.
5910 N. Central Expressway
Suite 1070 - Lock Box 45
Dallas,  TX  75206
Applicant Contact DOWBEN, MD
Correspondent
Tudor Laboratories, Inc.
5910 N. Central Expressway
Suite 1070 - Lock Box 45
Dallas,  TX  75206
Correspondent Contact DOWBEN, MD
Regulation Number862.3645
Classification Product Code
LEG  
Date Received09/06/1989
Decision Date 10/03/1989
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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