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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name O-Phthalaldehyde, Urea Nitrogen
510(k) Number K883327
Device Name CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
Applicant
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1770
Classification Product Code
JGZ  
Date Received08/08/1988
Decision Date 01/23/1989
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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