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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bromcresol green dye-binding, albumin
510(k) Number K991576
Device Name ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact GABRIEL J MURACA
Correspondent
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact GABRIEL J MURACA
Regulation Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CDQ   CEO   CFO   CFR   CGA  
CGS   CGX   CIC   CIG   CIT   CJK  
JFY   JIY   KHM   KNK   LBS  
Date Received05/06/1999
Decision Date 06/30/1999
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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