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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 K896235
Device Name COBAS READY ALBUMIN REAGENT
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
MONTCLAIR,  NJ  07042
Applicant Contact ALEX WESOLOWSKI
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
MONTCLAIR,  NJ  07042
Correspondent Contact ALEX WESOLOWSKI
Regulation Number862.1035
Classification Product Code
CIX  
Date Received10/30/1989
Decision Date 02/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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