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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K013959
Device Name BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact KENNETH T EDDS
Correspondent
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact KENNETH T EDDS
Regulation Number862.3200
Classification Product Code
DKB  
Date Received11/30/2001
Decision Date 01/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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