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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K903015
Device Name SYNERMED CHOLESTEROL REAGENT KIT
Applicant
SYNERMED, INC.
445 BOUL. INDUSTRIEL
ST-EUSTANCHE
QUEBEC,  CA J745R3
Applicant Contact MARCIA ARENTZ
Correspondent
SYNERMED, INC.
445 BOUL. INDUSTRIEL
ST-EUSTANCHE
QUEBEC,  CA J745R3
Correspondent Contact MARCIA ARENTZ
Regulation Number862.1175
Classification Product Code
CHH  
Date Received07/10/1990
Decision Date 10/01/1990
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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