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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K020792
Device Name ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Applicant
Bayer Diagnostics Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact KENNETH T EDDS
Correspondent
Bayer Diagnostics Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact KENNETH T EDDS
Regulation Number862.3030
Classification Product Code
LDP  
Date Received03/11/2002
Decision Date 07/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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