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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control
510(k) Number K000921
Device Name BAYER ADVIA IMS SYSTEM; 200 + 3
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 Number866.5580
Classification Product Code
DER  
Subsequent Product Codes
CFR   DFC  
Date Received03/22/2000
Decision Date 05/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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