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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K963939
Device Name SYNERMED DIRECT BILIRUBIN 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 Number862.1110
Classification Product Code
CIG  
Date Received10/01/1996
Decision Date 12/18/1996
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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