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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 K934533
Device Name BUN-300/BUN-500 UREA NITROGEN REAGENT
Applicant
Horizon Diagnostics, Inc.
3660 Plz. Dr.,Suite 4
Ann Arbor,  MI  48108
Applicant Contact P. R. PATEL
Correspondent
Horizon Diagnostics, Inc.
3660 Plz. Dr.,Suite 4
Ann Arbor,  MI  48108
Correspondent Contact P. R. PATEL
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received09/17/1993
Decision Date 11/26/1993
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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