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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K030452
Device Name BAYER LIGAND PLUS 1, 2, 3 CONTROLS
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 Number862.1660
Classification Product Code
JJY  
Date Received02/11/2003
Decision Date 03/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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