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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
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