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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 K843057
Device Name UREA ASSAY KIT
Applicant
DIAGNOSTIC CHEMICALS, LTD. (USA)
4 NEWLAND CRESCENT
CHARLOTTETOWN
CANADA, 
Correspondent
DIAGNOSTIC CHEMICALS, LTD. (USA)
4 NEWLAND CRESCENT
CHARLOTTETOWN
CANADA, 
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received08/03/1984
Decision Date 08/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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