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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Ammonia
510(k) Number K023841
Device Name AMMONIA ASSAY FOR THE ADVIA 1650
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact ANDRES HOLLE
Correspondent
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact ANDRES HOLLE
Regulation Number862.1065
Classification Product Code
JIF  
Subsequent Product Code
JIT  
Date Received11/18/2002
Decision Date 12/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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