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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 K863425
Device Name AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
Applicant
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Applicant Contact TIMOTHY J BELCASTRO
Correspondent
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Correspondent Contact TIMOTHY J BELCASTRO
Regulation Number862.1770
Classification Product Code
CDW  
Date Received09/04/1986
Decision Date 10/01/1986
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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