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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K924428
Device Name SYNERMED ENZYMATIC CO2 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 Number862.1160
Classification Product Code
KHS  
Date Received09/01/1992
Decision Date 12/03/1992
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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