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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K911248
Device Name SYNERMED UREA NITROGEN 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 Number862.1770
Classification Product Code
CDQ  
Date Received03/21/1991
Decision Date 06/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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