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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K974909
Device Name SYNERMED CREATININE REAGENT KIT
Applicant
Synermed Intl., Inc.
1688 50th Ave.
Lachine, Quebec,  CA H8T 2V5
Applicant Contact MARCIA J ARENTZ
Correspondent
Synermed Intl., Inc.
1688 50th Ave.
Lachine, Quebec,  CA H8T 2V5
Correspondent Contact MARCIA J ARENTZ
Regulation Number862.1225
Classification Product Code
CGX  
Date Received12/31/1997
Decision Date 02/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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