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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 K874532
Device Name BLOOD UREA NITROGEN
Applicant
Catachem, Inc.
6 N. Pearl St.
Port Chester,  NY  10573
Applicant Contact LUIS P LEON
Correspondent
Catachem, Inc.
6 N. Pearl St.
Port Chester,  NY  10573
Correspondent Contact LUIS P LEON
Regulation Number862.1770
Classification Product Code
CDW  
Date Received11/03/1987
Decision Date 01/05/1988
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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