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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, Carbamazepine
510(k) Number K000903
Device Name ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact FREDRICK CLERIE
Correspondent
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact FREDRICK CLERIE
Regulation Number862.3645
Classification Product Code
KLT  
Subsequent Product Code
LBZ  
Date Received03/21/2000
Decision Date 05/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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