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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 K992399
Device Name ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact GABRIEL J MURACAA JR
Correspondent
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact GABRIEL J MURACAA JR
Regulation Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CEM   CEO   CGZ   CHH   CHS  
CIG   JGS   KXT  
Date Received07/19/1999
Decision Date 09/15/1999
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
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