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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 K942984
Device Name BUN REAGENT
Applicant
AMERICAN RESEARCH PRODUCTS CO.
30175 SOLON INDUSTRIAL PKWY.
P.O. BOX 39098
SOLON,  OH  44139
Applicant Contact LEONARD C SZYMOWSKI
Correspondent
AMERICAN RESEARCH PRODUCTS CO.
30175 SOLON INDUSTRIAL PKWY.
P.O. BOX 39098
SOLON,  OH  44139
Correspondent Contact LEONARD C SZYMOWSKI
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received06/20/1994
Decision Date 03/01/1995
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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