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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 K960115
Device Name HICHEM BUN/UREA REAGENT KIT
Applicant
Elan Pharma, Inc.
231 N. Puente St.
Brea,  CA  92621
Applicant Contact WYNN STOCKING
Correspondent
Elan Pharma, Inc.
231 N. Puente St.
Brea,  CA  92621
Correspondent Contact WYNN STOCKING
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received01/11/1996
Decision Date 03/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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