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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 K964442
Device Name VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number862.3645
Classification Product Code
LEG  
Date Received11/06/1996
Decision Date 12/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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