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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(k) Number K802061
Device Name DATA-ZYME UREA NITROGEN REAGENT SET
Applicant
Data Medical Associates, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Data Medical Associates, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received08/25/1980
Decision Date 09/26/1980
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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