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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 K944250
Device Name UREA NITROGEN REAGENT
Applicant
Olympus Corp of America
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact LAURA S TYLER
Correspondent
Olympus Corp of America
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact LAURA S TYLER
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received09/01/1994
Decision Date 02/08/1995
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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