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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 K901123
Device Name CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact THOMAS C BREWSTER
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact THOMAS C BREWSTER
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received03/12/1990
Decision Date 05/10/1990
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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