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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diacetyl-Monoxime, Urea Nitrogen
510(k) Number K844156
Device Name UREA NITROGEN REAGENT SET
Applicant
Livonia Diagnostics, Inc.
33041 W. Eight Mile Rd.
Livonia,  MI  48152
Applicant Contact WALTER H LAMBERT
Correspondent
Livonia Diagnostics, Inc.
33041 W. Eight Mile Rd.
Livonia,  MI  48152
Correspondent Contact WALTER H LAMBERT
Regulation Number862.1770
Classification Product Code
CDW  
Date Received10/24/1984
Decision Date 11/13/1984
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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