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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K010201
Device Name BAYER ADVIA IMS SYSTEM
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact FREDICK CLERIE
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact FREDICK CLERIE
Regulation Number862.1215
Classification Product Code
MMI  
Date Received01/22/2001
Decision Date 03/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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