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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urinary homocystine (nonquantitative) test system
510(k) Number K013406
Device Name ADVIA CENTAUR HOMOCYSTEINE ASSAY
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact KENNETH T EDDS
Correspondent
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact KENNETH T EDDS
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Code
JIS  
Date Received10/15/2001
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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