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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K903164
Device Name EURAMARK 610 PHOTOMETER
Applicant
Euro-American Marketing Group, Inc.
610 S. Albert
P.O. Box 823
Mount Prospect,  IL  60056
Applicant Contact BRENDA BORDEWYK
Correspondent
Euro-American Marketing Group, Inc.
610 S. Albert
P.O. Box 823
Mount Prospect,  IL  60056
Correspondent Contact BRENDA BORDEWYK
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/18/1990
Decision Date 08/09/1990
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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