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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 K894173
Device Name BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
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
CDQ  
Date Received06/15/1989
Decision Date 09/05/1989
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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