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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferrozine (Colorimetric) Iron Binding Capacity
510(k) Number K922784
Device Name SYNERMED UIBC REAGENT KIT
Applicant
Synermed, Inc.
1688 50th Ave.,
Montreal (Lachine),
Quebec, Canada,  CA H8T 2V5
Applicant Contact MARCIA J ARENTZ
Correspondent
Synermed, Inc.
1688 50th Ave.,
Montreal (Lachine),
Quebec, Canada,  CA H8T 2V5
Correspondent Contact MARCIA J ARENTZ
Regulation Number862.1415
Classification Product Code
JMO  
Date Received06/09/1992
Decision Date 07/21/1992
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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