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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 NORTH PEARL ST.
PORT CHESTER,  NY  10573
Applicant Contact LUIS P LEON
Correspondent
CATACHEM, INC.
6 NORTH 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
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