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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 K852292
Device Name DURAZYME UREA NITROGEN
Applicant
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Applicant Contact LINDA M CHINN
Correspondent
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Correspondent Contact LINDA M CHINN
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received05/29/1985
Decision Date 07/08/1985
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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