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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Beta-2-Microglobulin Immunological
510(k) Number K993711
Device Name ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact GABRIEL MURACA
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact GABRIEL MURACA
Regulation Number866.5630
Classification Product Code
JZG  
Subsequent Product Codes
DDR   DHA   JHW   JLW   JMG  
Date Received11/03/1999
Decision Date 12/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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