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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 K903543
Device Name SYNERMED ALBUMIN REAGENT KIT
Applicant
SYNERMED, INC.
1688 50TH AVENUE,
MONTREAL (LACHINE),
QUEBEC, CANADA,  CA H8T 2V5
Applicant Contact MARCIA J ARENTZ
Correspondent
SYNERMED, INC.
1688 50TH AVENUE,
MONTREAL (LACHINE),
QUEBEC, CANADA,  CA H8T 2V5
Correspondent Contact MARCIA J ARENTZ
Regulation Number862.1035
Classification Product Code
CIX  
Date Received08/07/1990
Decision Date 10/12/1990
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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